Methods

Randomised trial.
A. Generation of allocation sequence: adequate. Computer generated random numbers.
B. Allocation concealment: unclear. No information.
C. Blinding: unclear. No information.
D. Follow‐up: adequate.

Inclusion of all randomised participants at evaluation: 1 patient from each group died before treatment and not included in the analysis.

Time from bleeding episode to randomisation: Three days after bleeding was controlled.
Time from randomisation to treatment in days (mean, SD): TIPS ( 8.4, 3.6), ET (2.7, 3.2). Total number of patients evaluated and found eligible: 63 (90 evaluated).
Randomised to TIPS: 31, randomised to ET: 32.
Adequate reasons provided for those not randomised: yes.
Nine patients in the ET group crossed over to TIPS during follow‐up.
There were no losses to follow‐up.
Intention to treat analysis.
Follow‐up period (mean days, SD)
TIPS (452, 298) range: 20 to 020 days.
ET (455, 298) range: 70 to 951 days.
Assessment of suitability for shunt carried out prior to randomisation: no.
Shunt patency assessed with angiography at six months or at the time of rebleeding.
Method of Child's grading: Child‐Pugh.
Method of encephalopathy testing: clinical. Rebleeding episodes endoscopically verified: yes.
Specified whether rebleeding episode clinically significant: yes.

Participants

Inclusion criteria: all cirrhotic patients admitted with an episode of acute oesophageal variceal bleeding.

Exclusions (one or more of the following): presence of gastric varices with active bleeding, episodes of chronic encephalopathy, severe acute alcoholic hepatitis, end‐stage cirrhosis, neoplastic disease, septicaemia and portal vein thrombosis.

The two groups comparable in‐terms of age, Child's status and number of alcoholic patients.

Interventions

ET:
sclerotherapy, intra‐ and para‐variceal technique, sclerosant = 1% polidocanol.

Shunt:
TIPS (wall and Strecker)

Outcomes

Incidence of rebleeding.
Incidence of complications.
Incidence of deaths.

Notes

Long‐term follow‐up published as abstract in Hepato‐Gastroenterology 1998, Third International Congress of Hepato‐Pancreato‐Biliary Association.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Duplicate publication of Cello 1987.

Participants

Interventions

Outcomes

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Randomised trial.
A. Generation of allocation sequence: unclear. No information.
B. Allocation concealment: adequate. Serially numbered opaque envelopes.
C. Blinding: unclear. No information.
D. Follow‐up: adequate.
Inclusion of all randomised participants at evaluation: yes.

Time from bleeding episode to randomisation, not mentioned.
Time from randomisation to treatment: six hours for shunt and two hours for endoscopic treatment. Total number of patients evaluated: 68.
Randomised to shunt: 32, randomised to ET: 32.
Adequate reasons provided for those not randomised ‐ yes.
Two patients in the shunt group did not receive the allocated treatment.
No losses to follow‐up.
Intention to treat analysis.
Mean follow‐up period (range): 530 days mean, 21 to 1830 days.
Assessment of suitability for shunt carried out prior to randomisation: no.
Method of Child's grading: single worst Child’s criteria.
Method of encephalopathy testing: clinical testing.
Rebleeding episodes endoscopically verified: yes.
Specified whether rebleeding episode clinically significant = yes.
(Only 16 patients in the shunt group and 14 in the ET group discharged alive after the initial hospitalisation).

Participants

Inclusion criteria: Child's C patients with actively bleeding varices confirmed on endoscopy, requiring six or more units of blood transfusion.

Exclusions: moribund patients. Pre‐treatment variables were comparable across the two groups other than active alcoholics which were significantly greater in the ES group.

Interventions

ET:
Sclerotherapy, intra‐variceal technique, sclerosant = sodium morrhuate.

Shunt:
Portocaval shunt.

Outcomes

Rebleeding.
Encephalopathy.
Survival.
Cost.

Notes

Only 16 patients in the shunt group and 14 in the ET group discharged after the index hospitalisation.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Randomised trial.
A. Generation of allocation sequence: unclear. No information.
B. Allocation concealment: adequate. Sealed, opaque envelopes.
C. Blinding: unclear. No information.
D. Follow‐up: adequate.
Inclusion of all randomised participants at evaluation: yes.

Time from bleeding episode to randomisation (mean, SD) = TIPS (35.4,5.6 hours), ET (37.4, 4.7 hours). Time from randomisation to treatment (mean, SD) = TIPS ( 59.5, 6.7 hours).
Total number of patients evaluated = 300. Randomised to TIPS = 24, randomised to ET = 25.
Adequate reasons provided for those not randomised. Reasons mentioned but numbers not provided.
One patient did not receive the allocated treatment in TIPS group and six patients in ET group were crossed over to TIPS during follow‐up.
Follow‐up period in days (mean, SD)
TIPS (575, 109)
ET (567, 104)
Assessment of suitability for shunt carried out prior to randomisation = yes.
Shunt patency assessed with Duplex scanning.
Method of Child's grading = Child‐Pugh, however, patients were not stratified according to the Child‐Pugh system.
Method of Encephalopathy testing = clinical.
Rebleeding episodes endoscopically verified = yes.
Specified whether rebleeding episode clinically significant = not stated.

Participants

Inclusion criteria: all patients admitted with massive or submassive acute gastrointestinal tract haemorrhage from large oesophageal varices.

Exclusions (one or more of the following): prisoners, <18 or >75 years of age, Cerebrovascular accident three months before the onset of bleeding, refusal to accept blood products, gastric variceal haemorrhage, ECG changes compatible with myocardial infarction, specified limits of PO2, creatinine, bilirubin, prothrombin time and platelet count measurements, Grade IV encephalopathy, cancer other than skin cancer, AIDS, sepsis, pneumonia, peritonitis, alcoholic hepatitis (clinical evidence only), thrombosis of portal, hepatic or inferior vena cava.
Patients across the two strata were comparable in‐terms of age, child score and alcoholics.

Interventions

ET:
Sclerotherapy, para‐variceal technique, sclerosant = ethanolamine oleate.

Shunt:
TIPS (wall stents).

Outcomes

Rebleeding.
Encephalopathy.
Survival.
Cost analysis.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Randomised trial.
A. Generation of allocation sequence: unclear. Randomisation mentioned, but method not specified.
B. Allocation concealment: unclear. No information.
C. Blinding: unclear.
D. Follow‐up: unclear.
Inclusion of all randomised participants at evaluation: exclusions less than 10%.

Time from variceal bleeding to therapy in days, mean (SD): TIPS 5.4 (2.1), ET 5.6 (2.2).
22 randomised in TIPS group and 24 in the ET group.
Follow‐up period in days mean (SD):
TIPS 760 (390),
ET 503 (460)
Assessment of suitability for shunt carried out prior to randomisation: not specified.
No cross‐overs, no information on attrition to follow‐up.
Shunt patency assessed with duplex scanning and portography at one month and then every six month.
Method of Child's grading: Child‐Pugh.
Method of encephalopathy testing: Parson‐Smith criteria.
Rebleeding episodes endoscopically verified: yes.
Specified whether rebleeding episode clinically significant: not specified.

Participants

Inclusion criteria: endoscopically proven oesophageal variceal bleeding, diagnosis of cirrhosis based on clinical history and laboratory, ultrasonography, and/ or liver biopsy findings, age between 18 to 75 years and informed consent from the patient.

Exclusions (one or more of the following): history of chronic encephalopathy, portal vein thrombosis, hepatocellular carcinoma and end‐stage liver disease.

Comparable with respect to age, gender, etiology. Endoscopic group had a significantly greater proportion of patients with pre‐existing encephalopathy but were comparable in‐terms of Child‐Pugh class.

Interventions

ET:
Sclerotherapy, ?intra‐variceal and para‐variceal technique, sclerosant = ethanolamine oleate.

Shunt:
TIPS (wall stent).

Outcomes

Rebleeding.
Survival.
Encephalopathy.
Rebleeding index.
Days spent as an in‐patient.
Causes of death.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomised trial (Abstract). Randomised to TIPS: 32; ET: 33.

Participants

Child's C cirrhotic patients presenting with variceal bleeding. Treated with sclerotherapy prior to randomisation.

Interventions

ET:
Sclerotherapy plus propranolol.

Shunt:
TIPS (type not specified).

Outcomes

Variceal rebleeding.
Survival.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Randomised trial.
A. Generation of allocation sequence: unclear. No information.
B. Allocation concealment: adequate. Sealed, opaque envelopes.
C. Blinding: unclear. No information.
D. Follow‐up: adequate.
Inclusion of all randomised participants at evaluation: yes.

Time from bleeding episode to randomisation (mean, SD) = TIPS 13, 3(days), ET 14, 3 (days). Time from randomisation to treatment = unclear.
Total number of patients evaluated = 86
Randomised to TIPS = 28, randomised to ET = 26.
Adequate reasons provided for those not randomised = yes.
Two patients did not receive the allocated treatment in TIPS group and six patients in ET group were crossed over to TIPS and one to a surgical shunt during follow‐up.
Follow‐up period in years (mean)
TIPS 1.8
ET 2 .
Assessment of suitability for shunt carried out prior to randomisation = yes.
Shunt patency assessed with Duplex scanning.
Method of Child's grading = Child‐Pugh, patients were stratified according to the Child‐Pugh system.
Method of encephalopathy testing = clinical.
Rebleeding episodes endoscopically verified = yes.
Specified whether rebleeding episode clinically significant = yes.

Participants

Inclusion criteria: age > 18 years, endoscopic evidence of variceal bleeding within 2 months before randomisation, stable heamodynamic condition.

Exclusion criteria: isolated gastric varices, isolated bleeding from gastric varices, large or diffuse liver tumour, liver transplantation intended in six months, hepatic encephalopathy > grade 2, Child Pugh >13, extra hepatic cholestasis, heart failure, sepsis, multi‐organ failure.

Interventions

ET:
Variceal band ligation.

TIPS:
Expandable 8‐10 mm stents.

Outcomes

Rebleeding.
Death.
Treatment failure.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Randomised trial.
A. Generation of allocation sequence: unclear. No information.
B. Allocation concealment: adequate. Serially numbered opaque envelopes.
C. Blinding: unclear. No information.
D. Follow‐up: adequate.
Inclusion of all randomised participants at evaluation: yes.

Time from bleeding episode to randomisation, not mentioned.
Time from randomisation to treatment: Six hours for shunt and two hours for endoscopic treatment. Total number of patients evaluated: 68.
Randomised to SHUNT: 32, randomised to ET: 32.
Adequate reasons provided for those not randomised ‐ yes.
Two patients in the shunt group did not receive the allocated treatment.
No losses to follow‐up.
Intention to treat analysis.
Mean follow‐up period (range): 530 days mean, 21 to 1830 days.
Assessment of suitability for shunt carried out prior to randomisation: no.
Method of Child's grading: single worst Child’s criteria.
Method of encephalopathy testing: clinical testing.
Rebleeding episodes endoscopically verified: yes.
Specified whether rebleeding episode clinically significant = yes.
(Only 16 patients in the shunt group and 14 in the ET group discharged alive after the initial hospitalisation).

Participants

Inclusion criteria: biopsy proven cirrhosis, endoscopic evidence of varices and suitability for a DSRS shunt established with angiography.

Exclusions (one or more of the following): living more than 200 miles from the base hospital, referred for specific therapy, previous chronic sclerotherapy, emergent or urgent surgery, noncirrhotic variceal bleed.
Patients comparable in‐terms of age, Child's class and alcoholics.

Interventions

ET:
Sclerotherapy, intra‐variceal and para‐variceal technique, sclerosant: 0.75 ‐1.0% sodium tetradecyl sulfate or 1.5 ‐2.0% sodium morrhuate.

Shunt:
DSRS (Warren).

Outcomes

Survival.
Rebleeding.
Hepatic function.
Hemodynamics and liver and spleen volumes.

Notes

Encephalopathy not considered as an outcome.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Randomised trial.
A. Generation of allocation sequence: unclear. Randomisation mentioned but method not specified.
B. Allocation concealment: adequate. Sealed opaque envelopes.
C. Blinding: unclear. No information.
D. Follow‐up: inadequate.
Inclusion of all randomised participants at evaluation: incomplete information.

Time from bleeding episode to randomisation and treatment: not specified, but patients were included after their variceal bleeding was arrested with emergency endoscopic sclerosis and if they fulfilled the entry criteria.
Total number of patients evaluated: 228.
Randomised to shunt: 24, randomised to ET: 21.
Adequate reasons provided for those not randomised: yes.
No patient was crossed over.
No losses to follow‐up.
Intention to treat analysis.
Follow‐up period in months (mean): shunt 69.5, ET 60.2.
Assessment of suitability for shunt carried out prior to randomisation: not specified.
Method of Child's grading: Child's (version not specified).
Method of encephalopathy testing: clinical and psychometric testing.
Rebleeding episodes endoscopically verified: not specified.
Specified whether rebleeding episode clinically significant: yes.
(Isaksson et al. were unable to assess encephalopathy in 7/24 patients in the shunt group and in 5/21 group in the ET group).

Participants

Inclusion criteria: age between 20 to 75 years, endoscopically verified varices as the source of bleeding, portal hypertension, biopsy confirmed cirrhosis.

Exclusions: not specified. Patients comparable in‐terms of age and Child's status but alcoholics slightly greater in the ES group.

Interventions

ET:
Sclerotherapy, submucosal, and paravariceal technique, sclerosant = ethoxy‐sclerol.

Shunt:
Interpositional 14 mm mesocaval Goretex shunt.

Outcomes

Survival.
Rebleeding.
Encephalopathy.
Complications.
Cost and hospital stay.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Randomised trial.
A. Generation of allocation sequence: unclear. Randomisation mentioned but method not specified.
B. Allocation concealment: adequate. Sealed envelopes in batches of 25.
C. Blinding: unclear. No information.
D. Follow‐up: adequate.
Inclusion of all randomised participants at evaluation: yes.

Time from bleeding episode to randomisation: 24 hours after cessation of bleeding.
Time from randomisation to treatment in days (mean): TIPS (2.2), VB ie, variceal banding (2.4).
Total number of patients evaluated and found eligible: 61 (105 evaluated).
Randomised to TIPS: 31, randomised to ET: 27.
Adequate reasons provided for those not randomised: yes.
Three patiens in the TIPS group did not receive the allocated treatment and six patients in the endoscopic therapy were crossed over to TIPS during follow‐up.
No losses to follow‐up.
Intention‐to‐treat analysis.
Follow‐up period months (mean, SD)
TIPS (15.7,10.2)
ET (16.8,10.9).
Assessment of suitability for shunt carried out prior to randomisation: yes.
Shunt patency assessed with duplex scanning and portography at one week, one month and then every six months.
Method of Child's grading: Child‐Pugh.
Method of encephalopathy testing: Parson‐Smith criteria.
Rebleeding episodes endoscopically verified: yes.
Specified whether rebleeding episode clinically significant: yes.

Participants

Inclusion criteria: all cirrhotic patients between 18 and 75 yrs of age who presented with a first (index) episode of variceal bleeding.

Exclusions (one or more of the following): rebleeding from varices from varices within 24 hours of initial endoscopy, bleeding from ectopic varices, previous endoscopic treatment for varices, malignancy, portal vein thrombosis.
Patients characteristic similar in the two groups.

Interventions

ET:
Variceal banding ligation, single application.

Shunt:
TIPS (wall stent).

Outcomes

Variceal rebleeding.
Survival.
Encephalopathy.
Complications: sepsis, shunt dysfunction.
Cost analysis and amount of time spent in‐patient.

Notes

Only trial to employ variceal banding.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Randomised trial.
A. Generation of allocation sequence: unclear. Randomisation by balanced design.
B. Allocation concealment: unclear. Not mentioned.
C. Blinding: unclear. No information.
D. Follow‐up: adequate.
Inclusion of all randomised participants at evaluation: yes.

Time from bleeding episode to randomisation: not mentioned.
Time from randomisation to treatment in days (mean): not mentioned.
Total number of patients evaluated and found eligible: 37 (55 evaluated).
Randomised to surgical shunt: 18, randomised to ET: 19.
Adequate reasons provided for those not randomised: no information.
No losses to follow‐up.
Follow‐up period months (mean, SD): ET 10.5 (9.5)
Shunt 13.1(8.8).
Assessment of suitability for shunt carried out prior to randomisation: not mentioned
Shunt patency assessed: no mention.
Method of Child's grading: Child‐Pugh.
Method of encephalopathy testing: not mentioned.
Rebleeding episodes endoscopically verified: no information.

Participants

Inclusion criteria: all patients with cirrhotic portal hypertension (Child‐Pugh A) with minimum of two variceal bleeding episodes who received less than one session of ET.

Exclusions: not mentioned.
Characteristic similar in the two groups.

Interventions

ET:
Sclerotherapy.

Shunt:
TS (13)
DSRS (3)
Meso‐caval (1).

Outcomes

Variceal rebleeding.
Survival.
Transfusion requirement.

Notes

Only trial to employ variceal banding.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomised trial.
A. Generation of allocation sequence: adequate. Randomisation in blocks of four, three centres had a separate list.
B. Allocation concealment: adequate. Sealed envelopes.
C. Blinding: unclear. No information.
D. Follow‐up: adequate.
Inclusion of all randomised participants at evaluation: yes.

Time from bleeding episode to randomisation: Three strata of time intervals used: I = acutely bleeding patients (one to seven days), II = patients referred from other centres following a bleed but without endoscopic treatment (one to six weeks), III = patients referred following various intervals after a variceal bleed for advice and treatment (seven weeks to six months).
Time from randomisation to treatment : According to strata specified but active bleeding had to have been controlled for a minimum of 24 hrs.
Total number of patients evaluated and found eligible: 82 (120 evaluated).
Randomised to TIPS: 39, randomised to ET: 43.
Adequate reasons provided for those not randomised: yes.
Two patients crossed over to ET from TIPS and six crossed over from ET to TIPS during follow‐up. Six patients in TIPS group and four patients in the ET group did not receive the allocated treatment.
One patient in each group lost to follow‐up.
Intention to treat analysis but one patient erroneously assigned to TIPS and excluded from the analysis.
Follow‐up period in weeks (mean, SE)
TIPS (77.7, 7.12)
ET (73.9, 7.3)
Assessment of suitability for shunt carried out prior to randomisation: yes.
Shunt patency assessed with Duplex ultrasound at six months or when shunt malfunction was suspected.
Method of Child's grading: Child‐Pugh.
Method of encephalopathy testing: Parson‐Smith criteria.
Rebleeding episodes endoscopically verified: yes.
Specified whether rebleeding episode clinically significant: yes.

Participants

Inclusion criteria: patients with variceal bleeding (proven or presumed) according to pre‐specified criteria.

Exclusions (one or more of the following): complete portal vein thrombosis, previous episode/s of chronic recurrent hepatic encephalopathy, advanced hepatocellular carcinoma, previous multiple sessions of sclerotherapy, ongoing pharmacological prophylaxis of rebleeding (one emergency session during the acute bleeding phase was permissible), severe cardio‐vascular contraindications; or concomitant morbid condition/s with a life expectancy of less than a year.
Patients characteristic comparable other than alcoholics which were higher in the endoscopic group.

Interventions

ET:
Sclerotherapy, technique not mentioned, sclerosant = 1‐2% polidocanol.

Shunt:
TIPS (wall or Strecker).

Outcomes

Rebleeding.
Encephalopathy.
Survival.
Treatment failure and complications.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Randomised trial.
A. Generation of allocation sequence: unclear. No information.
B. Allocation concealment: adequate. Sealed, opaque envelopes.
C. Blinding: unclear. No information.
D. Follow‐up: adequate.
Inclusion of all randomised participants at evaluation: yes.

Time from bleeding episode to randomisation (mean, S.D) = TIPS (19.1,2 days), ET (17.9,1.9). Time from randomisation to treatment (mean, SD) = Not clear.
Total number of patients evaluated = 101
Randomised to TIPS = 38, randomised to ET = 40.
Adequate reasons provided for those not randomised = yes.
One patient in ET group crossed over to TIPS during follow‐up.
Follow‐up period in days (mean, SD)
TIPS (1116,92)
ET (1047,102)
Assessment of suitability for shunt carried out prior to randomisation = no.
Shunt patency assessed with Duplex scanning.
Method of Child's grading = Child‐Pugh, however, patients were not stratified according to the Child‐Pugh system.
Method of Encephalopathy testing = Parson Smith criteria.
Rebleeding episodes endoscopically verified = yes.
Specified whether rebleeding episode clinically significant = not stated.

Participants

Inclusions: cirrhosis with recent variceal haemorrhage, clinical stability at randomisation, age between 20 to 69 years.

Exclusion criteria: hepatocellular carcinoma, episodes of chronic encephalopathy, portal vein thrombosis, Child‐Pugh > 13, serum creatinine >2.5 milligram per decilitre, serum bilirubin > 5 milligram per decilitre, active infection and severe cardiopulmonary disease.

Interventions

ET: Sclerotherapy using 5% ethanolamine
TIPS:
Rosch‐Uchida as well as wall stents (8 to 10 mm).

Outcomes

Rebleeding.
Death.
Hepatic encephalopathy.
Complications.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Randomised trial, reported as abstract only. Duplicate publication of P‐Layrargues 2001.

Participants

Interventions

Outcomes

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomised trial.
A. Generation of allocation sequence: unclear. Randomisation mentioned but method not specified.
B. Allocation concealment: unclear. No information.
C. Blinding: no information.
D. Follow‐up: adequate.
Inclusion of all randomised participants at evaluation: yes.

Time from bleeding to randomisation: After patients had been haemodynamically stabilised for 24 hours.
TIPS (hours): 44.
ET (hours): 42.
Time from randomisation to Traitement for TIPS (mean): 13 hours.
158 patients evaluated, reasons provided for those excluded: yes.
39 included in the ET group and 41 in the TIPS group.
Follow‐up period in days (mean).
TIPS: 678.
ET: 581.
Assessment of suitability for shunt carried out prior to randomisation: Yes.
Shunt patency assessed with duplex scanning at 24 hours and then 3 monthly.
Two patients in the TIPS group and four in the ET underwent transplantation, one patient crossed over from ET to TIPS.
Intention‐to‐treat analysis.
Method of Child's grading: Child‐Pugh.
Method of encephalopathy testing: clinical.
Rebleeding episodes endoscopically verified: yes.
Specified whether clinically significant : yes.

Participants

Inclusion criteria: cirrhosis, Child‐Pugh grade B and C, age between 18 to 75 years, with an episode of endoscopically verified variceal bleeding.

Exclusions: portal vein thrombosis, previous endoscopic therapy within three months, previous shunt, fundal varices, hepatocellular carcinoma, cardiac, renal or respiratory failure, non‐compliance, sepsis, and uncontrolled bleeding.

Interventions

ET:
Variceal band ligation.

Shunt:
TIPS (type not specified).

Outcomes

Survival.
Rebleeding.
Encephalopathy.
Shunt dysfunction.
Duration of hospital stay.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Duplicate publication of Teres 1987.

Participants

Interventions

Outcomes

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

D ‐ Not used

Methods

Randomised trial.
A. Generation of allocation sequence: unclear. Randomisation mentioned but method not specified.
B. Allocation concealment: unclear. No information.
C. Blinding: unclear. No information.
D. Follow‐up: adequate.
Inclusion of all randomised participants at evaluation: yes.

Time from bleeding episode to randomisation: Three days after stabilisation following a variceal bleed.
Time from randomisation to treatment, days (mean,SD): Shunt (14.7,6.3), ET (7.2,3.4).
Total number of patients evaluated: 189.
Randomised to SHUNT: 41, randomised to endoscopic therapy (ET): 41.
Adequate reasons provided for those not randomised: yes.
Seven patients in the shunt group and six in the ET group did not receive the allocated treatment.
One patient in each group was lost to follow‐up.
Intention to treat analysis.
Mean follow‐up period in months (SD): SHUNT 20.9 (13.9), ET 20.8 (15).
Assessment of suitability for shunt carried out prior to randomisation: no.
Method of Child's grading: Child‐Campbell.
Method of Encephalopathy testing: clinical testing and history.
Rebleeding episodes endoscopically verified: yes.
Specified whether rebleeding episode clinically significant: not specified.

Participants

Inclusion criteria: Child‐Campbell A and B cirrhotic patients who were considered following endoscopically proven variceal haemorrhage.

Exclusions (one or more of the following): Child‐Campbell class C, uncontrollable haemorrhage, or early rebleeding between admission and randomisation.
Patient characteristics comparable, age slightly less in the ES group.

Interventions

ET:
Sclerotherapy, intra‐ and para‐variceal technique, sclerosant polidocanol.

Shunt:
End‐to‐side portocaval shunt.

Outcomes

Rebleeding.
Encephalopathy.
Mortality.
Complications.
Days of hospitalisation and cost.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Duplicate publication of Rikkers 1993.

Participants

Interventions

Outcomes

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomised trial.
A. Generation of allocation sequence: adequate. Efron's biased coin design.
B. Allocation concealment: unclear. No information.
C. Blinding: unclear. No information.
D. Follow‐up: adequate.
Inclusion of all randomised participants at evaluation: one patient switched from shunt to ET.

Time from bleeding episode to randomisation: not specified.
Time from randomisation to treatment: not specified.
Randomised to shunt: 31 (DSRS 26, Total = 4), randomised to ET: 29.
(One patient switched to ET from shunt group after he withdrew consent and he was assessed as being randomised to ET.)
Adequate reasons provided for those not randomised: not specified.
Two patients in each group lost to follow‐up.
Per protocol analysis, non intention to treat.
Mean follow‐up period in months (SE): shunt 85.5 (5), ES 92 (7).
Assessment of suitability for shunt carried out prior to randomisation: yes.
Suitability for shunt assessed with angiography.
Method of Child's grading: modified Child's with four parameters.
Method of encephalopathy testing: clinical, EEG, psychometric, number connection test.
Rebleeding episodes endoscopically verified: yes.
Specified whether rebleeding episode clinically significant: not specified.

Participants

Inclusion criteria: portal hypertension secondary to cirrhosis, endoscopic documentation of acute or recent oesophageal variceal haemorrhage requiring a minimum transfusion of 3 U of blood, residence within 500 miles of Salt Lake City or Omaha, non‐operative control of acute variceal haemorrhage, patency of splenic and portal veins documented by selective angiography

Exclusions: not specified.
Patients comparable in the two groups.

Interventions

ET:
Sclerotherapy, intra‐variceal technique, sclerosant 0.75% sodium tetradecyl sulfate and 50% dextrose or 5% sodium morrhuate.

Shunts:
DSRS (n = 26),
side to side portocaval (n = 3), end‐to‐side portocaval (n = 1).

Outcomes

Survival.
Recurrent haemorrhage.
Therapy failure.
Quantitative liver function and haemodynamics.
Encephalopathy.
Cost.

Notes

Portacaval shunts were performed on 3 patients with medically intractable ascites and on 1 with massive rebleeding. SPD was not used in any of the patients.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomised trial.
A. Generation of allocation sequence: adequate. Computer generated random numbers.
B. Allocation concealment: adequate. Study groups read by person not involved in the clinical setting. Random setting could not be previewed.
C. Blinding: unclear. No information.
D. Follow‐up: adequate.
Inclusion of all randomised participants at evaluation: yes.

Time from bleeding episode to randomisation in hours (SD): TIPS 6.3 (5.5), ET 4.4 (5).
Time from randomisation to treatment: 48 hrs.
Total number of patients evaluated and found eligible: 190.
Randomised to TIPS: 61, randomised to ET: 65.
Adequate reasons provided for those not randomised: Not individually specified.
Three patients lost to follow‐up in TIPS group and one in ET group. Nine patients were crossed over from ET to TIPS during follow‐up.
Intention‐to‐treat analysis.
Follow‐up period in months (mean, interquartile range).
TIPS (14, 8‐23)
ET (13, 8‐25).
Assessment of suitability for shunt carried out prior to randomisation: Not mentioned.
Shunt patency assessed with Duplex ultrasound at 1,3, 6 ,9, and 12 months and then every six months.
Method of Child's grading: Child‐Pugh.
Method of encephalopathy testing = clinical testing, trail making test, mental state examination.
Rebleeding episodes endoscopically verified: yes.
Specified whether rebleeding episode clinically significant: yes.

Participants

Inclusion criteria: liver cirrhosis, variceal bleeding within 2 weeks before randomisation, and age over 18 years.

Exclusions (one or more of the following): hepatic encephalopathy grade 3 and 4, liver insufficiency (bilirubin more than 5mg/dl), cavernomatous portal‐vein thrombosis, advanced malignancy, contra‐indications to propranolol (obstructive lung disease, severe hypotension) and bleeding emergency
Patients comparable in the two groups.

Interventions

ET:
Sclerotherapy plus propranolol, technique of sclerotherapy not mentioned, sclerosant (number of patients): polidocanol (59), bucrylate or histoacryl and lipiodol mixture (5), fibrin glue (4), polidocanol plus bucrylate (8).

Shunts:
TIPS (Palmaz stent (n = 39), memotherm stent (n = 16), wallstent (n = 6).

Outcomes

Rebleeding.
Complications.
Encephalopathy.
Hospital stay and mortality.
Liver function and Child‐Pugh class.

Notes

Propranolol used in‐addition to sclerotherapy.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Randomised trial.
A. Generation of allocation sequence: adequate. Computer generated numbers.
B. Allocation concealment: adequate. Sealed opaque envelopes.
C. Blinding: unclear. Not mentioned.
D. Follow‐up: adequate.
Inclusion of all randomised participants at evaluation: yes.

Time from bleeding episode to randomisation: Clinical stability for at least 72 hours following a variceal bleed.
Time from randomisation to treatment: 72 hours.
Total number of patients evaluated and found eligible: 100.
Randomised to TIPS: 41, randomised to ET: 39.
Adequate reasons provided for those not randomised = yes.
Two patients lost to follow‐up in TIPS group and one in ET group. Six patients in ET group crossed over to TIPS during follow‐up. Five patients in the TIPS group and three in the ET group underwent hepatic transplantation.
Intention to treat analysis.
Follow‐up period in days (median)
TIPS (990)
ET (956).
Assessment of suitability for shunt carried out prior to randomisation: yes.
Shunt patency assessed with Duplex ultrasound at one week, one and three months and then every three months, angiography carried out at six monthly intervals.
Method of Child's grading: Child‐Pugh.
Method of encephalopathy testing: not mentioned.
Rebleeding episodes endoscopically verified: yes.
Specified whether rebleeding episode clinically significant: yes.

Participants

Inclusion criteria: clinical stability in the absence of re bleeding 72 hours following a variceal bleed.

Exclusions (one or more of the following): portal venous thrombosis, hepatoma, end‐stage cancer or systemic disease which would limit the patients life span to less than one year.
Patients slightly younger in the TIPS group.

Interventions

ET:
Sclerotherapy, intra‐variceal technique, sclerosant sodium morrhuate (patients on beta‐blockade prior to randomisation were asked to stop taking it for the duration of the follow‐up period).

Shunt:
TIPS (wall stent).

Outcomes

Rebleeding.
Survival.
Complications.
Rates or re‐hospitalisations.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Randomised trial.
A. Generation of allocation sequence: adequate. Computer generated random numbers.
B. Allocation concealment: unclear. No information.
C. Blinding: unclear. No information.
D. Follow‐up: adequate.
Inclusion of all randomised participants at evaluation: yes.

Time from bleeding episode to randomisation in days (SD): 1.1 days (1.1).
Time from randomisation to treatment in days (SD): 3.4 (2.8)
Total number of patients evaluated and found eligible: 98. Randomised to TIPS: 42, randomised to ET: 41.
Adequate reasons provided for those not randomised: yes.
No losses to follow‐up.
Five patients in ES group crossed over to TIPS during follow‐up.
Intention‐to‐treat analysis.
Assessment of suitability for shunt carried out prior to randomisation = yes.
Shunt patency assessed with Duplex ultrasound or angiography at three monthly intervals.
Method of Child's grading: Child‐Pugh.
Method of encephalopathy testing: clinical and trail making test.
Rebleeding episodes endoscopically verified: yes.
Specified whether rebleeding episode clinically significant: yes.

Median observation time in years
TIPS (1.6)
ET (1.4)
Assessment of suitability for shunt carried out prior to randomisation = not mentioned.
Shunt patency assessed with Duplex ultrasound and angiography at three monthly intervals.
Method of Child's grading = Child‐Pugh.
Method of encephalopathy testing = clinical and trail‐making tests.
Rebleeding episodes endoscopically verified = yes.
Specified whether rebleeding episode clinically significant = no.

Participants

Inclusion criteria: cirrhosis and acute oesophageal haemorrhage.

Exclusions (one or more of the following): gastric varices, prior endoscopic or surgical treatment for varices, portal venous thrombosis, hepatoma, end‐stage cancer or systemic disease which would limit the patients life span to less than six months and uncontrolled bleeding requiring an emergency TIPS procedure.
Slightly younger patients in the TIPS group.

Interventions

ET:
Sclerotherapy plus propranolol, sclerotherapy intra‐variceal and para‐variceal technique, sclerosant = 5% ethanolamine oleate.

Shunt:
TIPS (Palmaz stent).

Outcomes

Rebleeding.
Mortality.
Encephalopathy.
Complications.

Notes

Propranolol used in‐addition to sclerotherapy.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomised trial (abstract). 85 patients randomised to TIPS (43) or EB 42).

Participants

Patients with cirrhosis and portal hypertension.

Interventions

ET:
Variceal band ligation.

Shunt:
TIPS (Palmaz stent ).

Outcomes

Rebleeding.
Survival.
Encephalopathy.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomised trial.
A. Generation of allocation sequence: adequate. Computer generated random numbers.
B. Allocation concealment: unclear. No information.
C. Blinding: unclear. No information.
D. Follow‐up: adequate.
Inclusion of all randomised participants at evaluation: yes.

Time from bleeding episode to randomisation in days : 1.2 ‐ 3.2.
Time from randomisation to treatment in days (SD): 2.4 ‐ 3.1.

Total number of patients evaluated and found eligible: 112. Randomised to TIPS: 43, randomised to ET: 42.
Adequate reasons provided for those not randomised: yes.
No losses to follow‐up.
Three patients in ET group crossed over to TIPS during follow‐up.
Intention to treat analysis.
Assessment of suitability for shunt carried out prior to randomisation = yes.
Shunt patency assessed with Duplex ultrasound or angiography at three monthly intervals.
Method of Child's grading: Child‐Pugh.
Method of encephalopathy testing: clinical.

Rebleeding episodes endoscopically verified: yes.
Specified whether rebleeding episode clinically significant: yes.

Mean observation time in years
TIPS (4.1)
ET (3.6).
Assessment of suitability for shunt carried out prior to randomisation = not mentioned.
Shunt patency assessed with Duplex ultrasound and angiography at three monthly intervals.
Method of Child's grading = Child‐Pugh
Method of encephalopathy testing = clinical.
Rebleeding episodes endoscopically verified = yes.
Specified whether rebleeding episode clinically significant = no.

Participants

Inclusion criteria: cirrhosis and acute first oesophageal haemorrhage.

Exclusions (one or more of the following): gastric varices, prior endoscopic or surgical treatment for varices, portal venous thrombosis, hepatoma, end‐stage cancer or systemic disease which would limit the patients life span to less than six months and uncontrolled bleeding.

Interventions

ET:
Variceal band ligation plus propranolol.

Shunt:
TIPS (Palmaz stent) or wallstents (Schneider).

Outcomes

Rebleeding.
Mortality.
Encephalopathy.
Complications.

Notes

Propranolol used in‐addition to variceal banding

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Randomised trial.
A. Generation of allocation sequence: adequate. Random number table.
B. Allocation concealment: unclear. No information.
C. Blinding: unclear. No information.
D. Follow‐up: adequate.
Inclusion of all randomised participants at evaluation: yes.

Time from bleeding episode to randomisation: ? When the patient achieved haemodynamic stability.
Time from randomisation to treatment: 24 hours.
Total number of patients evaluated: 77.
Adequate reasons provided for not randomising: yes.
Randomised to SHUNT: 20, randomised to ET: 20.
No losses to follow‐up.
Mean follow‐up period in months: shunt 29.2, ET 23.8.
Confidence interval in months: (24.2 to 34.1), (23.8 to 30.3).
Assessment of suitability for shunt carried out prior to randomisation: yes.
Method of Child's grading: Child‐Pugh.
Method of encephalopathy testing: mental status, asterixis, trail making tests, EEG.
Rebleeding episodes endoscopically verified: mes.
Specified whether rebleeding episode clinically significant: mes.

Participants

Inclusion criteria: biopsy confirmed cirrhosis, endoscopically verified variceal bleed requiring at least one unit of blood transfusion, arrest of variceal haemorrhage either spontaneously or by the use drugs and or tamponade and or sclerotherapy, good liver function as reflected by Child‐Pugh class A and B, patency of the portal venous system, eligible for either shunt or sclerotherapy, absence of life threatening diseases and willingness to return for regular follow‐up.

Exclusions: not specified.
Patients in the ES group slightly older and with a larger number of alcoholics.

Interventions

ET:
Sclerotherapy, intra‐variceal and para‐variceal technique, sclerosant 0.5% to 1% polidocanol.

Shunt:
DSRS (Warren).

Outcomes

Rebleeding.
Mortality.
Encephalopathy.
Mortality.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomised trial.
A. Generation of allocation sequence: adequate. Random number table.
B. Allocation concealment: adequate. Sealed envelopes.
C. Blinding: unclear. No information.
D. Follow‐up: adequate.
Inclusion of all randomised participants at evaluation: yes.

Time from bleeding episode to randomisation: 10 to 15 days.
Time from randomisation to treatment in DSRS group in days: 11‐65.
Total number of patients evaluated: 189.
Randomised to SHUNT: 57, randomised to ET: 55.
14 patients in the shunt group and 55 patients in the endoscopic group did not receive the allocated treatment and were excluded, reasons provided.
Two patients in the endoscopic group were lost to follow‐up.
Mean follow‐up period in months (SD): shunt 27.45 (15.6), ES 26.5 (16.9).
Follow‐up range in months DSRS (1‐58), ET (1‐64).
Assessment of suitability for shunt carried out prior to randomisation: no.
Method of Child's grading: Child‐Campbell.
Method of encephalopathy testing: clinical testing and history.
Rebleeding episodes endoscopically verified: yes.
Specified whether rebleeding episode clinically significant: not specified.

Participants

Inclusion criteria: Child‐Campbell A and B cirrhotic patients with at least one episode of variceal haemorrhage.

Exclusions (one or more of the following): continual variceal bleeding despite medical treatment and early rebleeding between admission and randomisation.
Child‐Campbell score greater and number of alcoholics greater in the ES group.

Interventions

ET:
Sclerotherapy, technique ?intra‐variceal, sclerosant 5% ethanolamine oleate.

Shunt:
DSRS (retroperitoneal approach).

Outcomes

Mortality.
Rebleeding.
Hepatic encephalopathy.
Complications.
Days of hospitalisation.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate