Pylorus‐preserving pancreaticoduodenectomy (pp Whipple) versus pancreaticoduodenectomy (classic Whipple) for surgical treatment of periampullary and pancreatic carcinoma

Markus K Diener; Christina Fitzmaurice; Guido Schwarzer; Christoph M Seiler; Felix J Hüttner; Gerd Antes; Hanns‐Peter Knaebel; Markus W Büchler

doi:10.1002/14651858.CD006053.pub5

Pylorus‐preserving pancreaticoduodenectomy (pp Whipple) versus pancreaticoduodenectomy (classic Whipple) for surgical treatment of periampullary and pancreatic carcinoma

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Referencias

References to studies included in this review

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otras versiones publicadas

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References to other published versions of this review

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estudios excluidos
otras referencias

Diener MK, Knaebel HP, Heukaufer C, Antes G, Buchler MW, Seiler CM. A systematic review and meta‐analysis of pylorus‐preserving versus classical pancreaticoduodenectomy for surgical treatment of periampullary and pancreatic carcinoma. Annals of Surgery 2007;245(2):187‐200.

Diener MK, Heukaeufer C, Schwarzer G, Seiler CM, Antes G, Knaebel H‐P, et al. Pancreaticoduodenectomy (classic Whipple) versus pylorus‐preserving pancreaticoduodenectomy (pp Whipple) for surgical treatment of periampullary and pancreatic carcinoma. Cochrane Database of Systematic Reviews 2008, Issue 2. [DOI: 10.1002/14651858.CD006053.pub2]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

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estudios excluidos

Bloechle 1999

Methods	Method of randomisation: unknown Number randomly assigned: 44 (PPW = 23, CW = 21) Exclusion after randomisation (total and per group): none Losses to follow‐up: yes Method of allocation concealment: unknown Intention‐to‐treat analysis: no Description of sample size calculation: none
Participants	Age, years: 69 (47 to 76) (median and range in the PPW group); 67 (43 to 78) (median and range in the CW group) Sex ratio (m/f): 1.6 (PPW), 1.5 (CW) Inclusion criteria: patients with periampullary carcinoma (cT1‐4, cN0‐1, cM0) Exclusion criteria: none Equivalence of baseline characteristics: age and stage distribution similar for both groups
Interventions	PPW and CW (no operation details available) Erythromycin application unknown Somatostatin application unknown
Outcomes	Description of outcome parameters: insufficient Operation time (minutes): PPW: 239 ± 79; CW: 285 ± 91 Mortality: PPW: 0%; CW: 0% DGE: PPW: 8 (34%); CW: 2 (9%)
Notes	Country: Germany Time of enrolment: unknown Duration of follow‐up: median 18 months (range 12 to 30) The trial investigator did not define the term ‘periampullary cancer’; it is assumed that it includes patients with pancreatic head cancer
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: not reported
Allocation concealment (selection bias)	Unclear risk	Comment: not reported
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Comment: not reported
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Comment: not reported
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: not reported
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: Postrandomisation dropouts could have influenced effect estimates
Selective reporting (reporting bias)	Unclear risk	Comment: no study protocol available
Other bias	High risk	Comment: sample size calculation not reported

Lin 1999

Methods	Method of randomisation: unknown Number randomly assigned: 33 (PPW = 14, CW = 19) Exclusion after randomisation (total and per group): 3 (PPW = 3, CW = 0) Losses to follow‐up: yes Method of allocation concealment: unknown Intention‐to‐treat analysis: no Description of sample size calculation: none
Participants	Age, years: 64.5 (48 to 77) (mean and range in the PPW group); 66.7 (46 to 84) (mean and range in the CW group) Sex: ratio (m/f): 2.5 (PPW), 2.2 (CW) Inclusion criteria: patients with pancreatic head carcinoma Exclusion criteria: none Equivalence of baseline characteristics: Participants were equivalent in terms of age and sex distribution; the CW group included more participants with stage III cancer
Interventions	PPW and CW (no operation details available) No somatostatin used Erythromycin application unknown
Outcomes	Operation time (minutes): PPW: 221 ± 35; CW: 271 ± 65 Blood loss (mL): PPW: 446 ± 342; CW: 1212 ± 194 Blood replacement (units): PPW: 1.0 ± 1.4; CW: 1.6 ± 2.6 Mortality: PPW: 1 (7.1%); CW: 0 (0%) DGE: PPW: 6 (42.8%); CW: 0 (0%) Bleeding: PPW: 0 (0%); CW: 1 (5.2%) Fistula: PPW: 1 (7.1%); CW: 1 (5.2%) Bile leak: PPW: 0 (0%); CW: 0 (0%) Wound infection: PPW: 1 (7.1%); CW: 1 (5.2%) Intra‐abdominal abscess: PPW: 0 (0%); CW: 1 (5.2%)
Notes	Country: Taiwan Time of enrolment: 156 weeks Duration of follow‐up: unknown All operations performed by the same surgeon
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: not reported
Allocation concealment (selection bias)	Unclear risk	Comment: not reported
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Comment: not reported
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Comment: not reported
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: not reported
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: Postrandomisation dropouts could have influenced effect estimates
Selective reporting (reporting bias)	Unclear risk	Comment: no study protocol available
Other bias	High risk	Comment: sample size calculation not reported

Paquet 1998

Methods	Method of randomisation: sealed envelopes (information from study author) Number randomly assigned: 40 (PPW = 17, CW = 23) Exclusion after randomisation (total and per group): unknown Losses to follow‐up: unknown Method of allocation concealment: unknown Intention‐to‐treat analysis: no Description of sample size calculation: none
Participants	Age, years: unknown Sex: unknown Inclusion criteria: patients with pancreatic adenocarcinoma or periampullary cancer and an R0 resection Exclusion criteria: none Equivalence of baseline characteristics: unknown
Interventions	Anastomoses: retrocolic end‐to‐end pancreaticojejunostomy with a drain in the pancreatic duct, end‐to‐end hepaticojejunostomy, end‐to‐end duodenojejunostomy Erythromycin application unknown Somatostatin application unknown
Outcomes	Description of outcome parameters: insufficient Mortality: PPW: 0 (0%); CW: 1 (4%) DGE: PPW: 6 (35%); CW: 1 (4%) Fistula: PPW: 1 (6%); CW: 2 (9%) Radicality (R0): PPW: 17 (100%); CW: 23 (100%) (condition for inclusion)
Notes	Country: Germany Time of enrolment: 521 weeks Duration of follow‐up: minimum = 24 months, maximum = 144 months
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: not reported
Allocation concealment (selection bias)	Unclear risk	Comment: "Sealed envelopes" were used (information obtained from the study author upon request)
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Comment: not reported
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Comment: not reported
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: no postrandomisation dropouts reported
Selective reporting (reporting bias)	Unclear risk	Comment: no study protocol available
Other bias	High risk	Comment: sample size calculation not reported

Seiler 2005

Methods	Method of randomisation: sealed envelopes Number randomly assigned: 130 (PPW = 64, CW = 66) Exclusion after randomisation (total): 84 (group distribution unknown) Losses to follow‐up: unknown Method of allocation concealment: unknown Intention‐to‐treat analysis: no Description of sample size calculation: yes
Participants	Age, years: 64.8 (26 to 83) (median and range in the PPW group); 65 (33 to 86) (median and range in the CW group) Sex: ratio (m/f): 1.29 (PPW), 1 (CW) Inclusion criteria: all patients suitable for surgery, with suspected pancreatic or periampullary cancer considered resectable on the basis of computed tomography or magnetic resonance imaging, with no history of previous gastric resection Exclusion criteria: direct tumour invasion of the proximal duodenum, pylorus or stomach; peripyloric lymph node metastases confirmed by intraoperative frozen‐section examination; distant metastases or locally unresectable tumours due to major retroperitoneal infiltration; emergency resections; necessity for total pancreatectomy to achieve clear resection margins Equivalence of baseline characteristics: Groups were similar regarding age, sex and stage distribution
Interventions	Reconstruction performed by means of an interrupted 2‐layer end‐to‐side pancreatojejunostomy, an end‐to side hepaticojejunostomy 10 to 15 cm distal to the pancreatic anastomosis and an end‐to‐side gastrojejunostomy/duodenojejunostomy approximately 40 cm distal to the biliodigestive anastomosis, followed by a Braun jejunojejunostomy Somatostatin application: 100‐200 µg 3 × 1 (7 days) Erythromycin application: none Perioperative treatment: antibiotic prophylaxis
Outcomes	Operation time (minutes): PPW: 382 (240 to 645); CW: 449 (240 to 780) Blood loss (mL): PPW: 1198 (400 to 4000); CW: 1500 (400 to 6000) Blood replacement (units): PPW: 0.9 (0 to 6); CW: 1.9 (0 to 10) Hospital stay (days): PPW: 19.7 (10 to 61); CW: 20.8 (8 to 67) Mortality: PPW: 1 (2%); CW: 2 (3%) DGE: PPW: 20 (31%); CW: 30 (45%) Bleeding: PPW: 2 (3%); CW: 4 (6%) Fistula: PPW: 2 (3%); CW: 1 (2%) Bile leak: PPW: 0 (0%); CW: 1 (1.5%) Infection (wound or abscess): PPW: 4 (6%); CW: 4 (6%) Positive LNs: PPW: 33 (62%); 41 (72%) Radicality (R0): PPW: 48 (91%); 45 (79%)
Notes	Country: Germany Time of enrolment: 274 weeks Duration of follow‐up: median = 63.1 months, minimum = 4 months, maximum = 93 months
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: not reported
Allocation concealment (selection bias)	Unclear risk	Comment: envelopes used for randomisation but unclear whether envelopes were opaque
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Comment: not reported
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Comment: not reported
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: no postrandomisation dropouts
Selective reporting (reporting bias)	Unclear risk	Comment: not reported
Other bias	Low risk	—

Tran 2004

Methods	Method of randomisation: sealed envelopes Number randomly assigned: 170 (PPW = 87, CW = 83) Exclusion after randomisation (total and per group): 36 (PPW = 17, CW = 19) Losses to follow‐up: unknown Method of allocation concealment: unknown Intention‐to‐treat analysis: yes Description of sample size calculation: yes
Participants	Age, years: 64 (43 to 78) (median and range in the PPW group); 62 (27 to 78) (median and range in the CW group) Sex: ratio (m/f): 2.32 (PPW), 1.35 (CW) Inclusion criteria: inclusion of consecutive patients with suspected pancreatic or periampullary cancer that was assumed to be resectable according to preoperative diagnostic imaging Exclusion criteria: previous gastric resection, distant metastasis or local unresectable tumours, direct invasion of the pylorus or stomach, positive peripyloric lymph nodes Equivalence of baseline characteristics: groups similar regarding age, sex and stage distribution
Interventions	End‐to‐side invaginated pancreaticojejunostomy, end‐to‐side hepaticojejunostomy, side‐to‐side gastroenterostomy or end‐to‐side pylorus‐jejunostomy Somatostatin application: 100 µg preoperatively + 3 × 1 postoperatively (7 days) Erythromycin application: none Perioperative treatment: antibiotic prophylaxis, H2‐receptor antagonists, drain in operation area
Outcomes	Operation time (minutes): PPW: 300 (130 to 600); CW: 300 (160 to 480) Blood loss (mL): PPW: 2000 (400 to 21,000); CW: 2000 (300 to 9500) Blood replacement (units): PPW: 2; CW: 2 Hospital stay (days): PPW: 18 (4 to 175); CW: 20 (11 to 138) Mortality: PPW: 3 (3%); CW: 6 (7%) DGE: PPW: 19/85 (22%); CW: 18/80 (23%) Bleeding: PPW: 6 (7%); CW: 6 (7%) Fistula: PPW: 11 (13%); CW: 12 (14%) Bile leak: PPW: 2 (2%); CW: 0 (0%) Intra‐abdominal abscess: PPW: 9 (10%); CW: 8 (10%) Re‐laparotomy: PPW: 13 (15%); CW: 16 (19%) Positive LNs: PPW: 37/72 (51.4%); 38/69 (55%) Radicality (R0): 53/72 (73.6%); 57/69 (82.6%)
Notes	Country: Germany Time of enrolment: 465 weeks Duration of follow‐up: median = 18.5 months, minimum = 1 month, maximum = 115 months
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: not reported
Allocation concealment (selection bias)	Low risk	Quote: "An equal number of blind envelopes with protocols for the SW and the PPPD resection was prepared. The envelopes were used sequentially as patients were enrolled in the study. Therefore, there was strict randomization in both arms. Randomization was carried out in the operation room: a sealed envelope was opened only after it was ascertained that both operation techniques were feasible in the patient concerned"
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Comment: not reported
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Comment: not reported
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: Reasons for exclusion from long‐term survival analysis are given (e.g. non‐malignant disease)
Selective reporting (reporting bias)	Unclear risk	Comment: not reported
Other bias	Low risk

Wenger 1999

Methods	Method of randomisation: unknown Number randomly assigned: 48 (PPW = 24, CW = 24) Exclusion after randomisation (total and per group): none Method of allocation concealment: unknown Intention‐to‐treat analysis: no Description of sample size calculation: none
Participants	Age, years: 61.2 ± 7.2 (mean and SD in the PPW group); 61.6 ± 8.9 (mean and SD in the CW group) Sex: ratio (m/f): 1 (PPW), 1 (CW) Inclusion criteria: all patients with a preoperative diagnosis of a ductal carcinoma of the pancreatic head or a periampullary carcinoma, an R0 resection and postoperative affirmation of the diagnosis Exclusion criteria: tumour infiltration of the stomach, the superior part of the duodenum or the pylorus; age > 75; peritoneal carcinosis; reduced general condition; heart insufficiency; renal insufficiency; hepatic insufficiency; pulmonary insufficiency Equivalence of baseline characteristics: groups similar regarding age, sex and stage distribution
Interventions	PPW and CW (no description of procedures) Somatostatin application: unknown Erythromycin application: unknown
Outcomes	Operation time (minutes): PPW: 206 ± 48; CW: 306 ± 54 Blood replacement (units): PPW: 5.5 ± 3.1; CW: 6.3 ± 5.2 Hospital stay (days): PPW: 19.1 ± 11.3; CW: 20.9 ± 13.8 Wound infection: PPW: 3 (12.5%); CW: 4 (16.6%) Positive LNs: PPW: 12 (50%); 13 (54%) Radicality (R0): PPW: 24 (100%); 24 (100%)
Notes	Country: Germany Time period for enrolment: 208 weeks Follow‐up: assessed at 2, 6, 12, 24, 36, 48 and 60 weeks; median and range not available
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: not reported
Allocation concealment (selection bias)	Unclear risk	Comment: not reported
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Comment: not reported
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Comment: not reported
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: no postrandomisation dropouts
Selective reporting (reporting bias)	Unclear risk	Comment: not reported
Other bias	High risk	Comment: sample size calculation not reported

CW: Classic Whipple.

DGE: Delayed gastric emptying.

LNs: Lymph nodes.

μg: Micrograms.

mL: Millilitres.

PPW: Pylorus‐preserving Whipple.

SD: Standard deviation.

Characteristics of excluded studies [ordered by study ID]

Ir a:

estudios incluidos

Study	Reason for exclusion
Bakkevold 1993	Non‐randomised study design; no comparison of PPW versus CW
Bassi 1994	No comparison of PPW versus CW
Bell 2005	Narrative review of 1 included RCT
Brennan 1994	No comparison of PPW versus CW
Buchler 1993	No comparison of PPW versus CW
Chou 1996	No comparison of PPW versus CW
Farnell 2005	No comparison of PPW versus CW
Friess 1996	No comparison of PPW versus CW
Johnstone 1993	No comparison of PPW versus CW
Nguyen 2003	No comparison of PPW versus CW
Pedrazzoli 1998	No comparison of PPW versus CW
Seiler 2000	Additional publication on the same trial (Seiler 2005). No additional information
Shan 2003	No comparison of PPW versus CW
van Berge Henegouwen	Non‐randomised study design; insufficient quantitative outcome parameters
Wagner 2004	Non‐randomised study design
Yeo 1999	Study randomised not for the comparison of PPW versus CW

CW: Classic Whipple.

PPW: Pylorus‐preserving Whipple.

RCT: Randomised controlled trial.

Data and analyses

Open in table viewer

Comparison 1. Survival

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Overall Show forest plot	3		Hazard ratio (Random, 95% CI)	0.84 [0.61, 1.16]
Open in figure viewer Analysis 1.1 Comparison 1 Survival, Outcome 1 Overall.
2 Pancreatic head carcinoma Show forest plot	3		Hazard ratio (Random, 95% CI)	0.73 [0.43, 1.22]
Open in figure viewer Analysis 1.2 Comparison 1 Survival, Outcome 2 Pancreatic head carcinoma.
3 Periampullary cancer Show forest plot	2		Hazard ratio (Random, 95% CI)	0.83 [0.39, 1.76]
Open in figure viewer Analysis 1.3 Comparison 1 Survival, Outcome 3 Periampullary cancer.

Open in table viewer

Comparison 2. Mortality

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Postoperative mortality Show forest plot	5	417	Odds Ratio (M‐H, Random, 95% CI)	0.49 [0.17, 1.40]
Open in figure viewer Analysis 2.1 Comparison 2 Mortality, Outcome 1 Postoperative mortality.

Open in table viewer

Comparison 3. Pancreatic fistula

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pancreatic fistula Show forest plot	5	421	Odds Ratio (M‐H, Random, 95% CI)	0.86 [0.41, 1.81]
Open in figure viewer Analysis 3.1 Comparison 3 Pancreatic fistula, Outcome 1 Pancreatic fistula.

Open in table viewer

Comparison 4. Delayed gastric emptying (with sensitivity analysis)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 All studies Show forest plot	5	412	Odds Ratio (M‐H, Random, 95% CI)	2.35 [0.72, 7.61]
Open in figure viewer Analysis 4.1 Comparison 4 Delayed gastric emptying (with sensitivity analysis), Outcome 1 All studies.
2 Studies in which DGE was defined (includes different definitions) Show forest plot	3	328	Odds Ratio (M‐H, Random, 95% CI)	1.14 [0.35, 3.68]
Open in figure viewer Analysis 4.2 Comparison 4 Delayed gastric emptying (with sensitivity analysis), Outcome 2 Studies in which DGE was defined (includes different definitions).
3 Studies with the same definitions of DGE Show forest plot	2	198	Odds Ratio (M‐H, Random, 95% CI)	4.02 [0.14, 119.16]
Open in figure viewer Analysis 4.3 Comparison 4 Delayed gastric emptying (with sensitivity analysis), Outcome 3 Studies with the same definitions of DGE.

Open in table viewer

Comparison 5. Biliary leakage

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Biliary leakage Show forest plot	3	333	Odds Ratio (M‐H, Random, 95% CI)	1.35 [0.10, 18.55]
Open in figure viewer Analysis 5.1 Comparison 5 Biliary leakage, Outcome 1 Biliary leakage.

Open in table viewer

Comparison 6. Intraoperative blood loss

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Intraoperative blood loss (litres) Show forest plot	1	33	Mean Difference (IV, Random, 95% CI)	‐0.76 [‐0.96, ‐0.56]
Open in figure viewer Analysis 6.1 Comparison 6 Intraoperative blood loss, Outcome 1 Intraoperative blood loss (litres).

Open in table viewer

Comparison 7. Red blood cell transfusion

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Red blood cell transfusion Show forest plot	2	79	Mean Difference (IV, Random, 95% CI)	‐0.65 [‐1.92, 0.61]
Open in figure viewer Analysis 7.1 Comparison 7 Red blood cell transfusion, Outcome 1 Red blood cell transfusion.

Open in table viewer

Comparison 8. Operating time

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Operating time (minutes) Show forest plot	3	125	Mean Difference (IV, Random, 95% CI)	‐68.26 [‐105.70, ‐30.83]
Open in figure viewer Analysis 8.1 Comparison 8 Operating time, Outcome 1 Operating time (minutes).

Open in table viewer

Comparison 9. Postoperative bleeding

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Postoperative bleeding Show forest plot	3	333	Odds Ratio (M‐H, Random, 95% CI)	0.74 [0.29, 1.88]
Open in figure viewer Analysis 9.1 Comparison 9 Postoperative bleeding, Outcome 1 Postoperative bleeding.

Open in table viewer

Comparison 10. Wound infection

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Wound infection Show forest plot	4	251	Odds Ratio (M‐H, Random, 95% CI)	0.85 [0.35, 2.05]
Open in figure viewer Analysis 10.1 Comparison 10 Wound infection, Outcome 1 Wound infection.

Open in table viewer

Comparison 11. Pulmonary complications

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pulmonary complications Show forest plot	3	218	Odds Ratio (M‐H, Random, 95% CI)	0.67 [0.29, 1.58]
Open in figure viewer Analysis 11.1 Comparison 11 Pulmonary complications, Outcome 1 Pulmonary complications.

Open in table viewer

Comparison 12. Necessity for reoperation

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Necessity for reoperation Show forest plot	2	300	Odds Ratio (M‐H, Random, 95% CI)	0.82 [0.38, 1.75]
Open in figure viewer Analysis 12.1 Comparison 12 Necessity for reoperation, Outcome 1 Necessity for reoperation.

Open in table viewer

Comparison 13. Hospital stay

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Hospital stay (days) Show forest plot	1	48	Mean Difference (IV, Random, 95% CI)	‐1.80 [‐8.94, 5.34]
Open in figure viewer Analysis 13.1 Comparison 13 Hospital stay, Outcome 1 Hospital stay (days).

Figure 1

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Figure 3

Study flow diagram.

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Figure 4

Funnel plot of comparison: 1 Survival, outcome: 1.1 Overall.

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Figure 5

Funnel plot of comparison: 2 Mortality, outcome: 2.1 Postoperative mortality.

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Figure 6

Funnel plot of comparison: 3 Pancreatic fistula, outcome: 3.1 Pancreatic fistula.

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Analysis 1.1

Comparison 1 Survival, Outcome 1 Overall.

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Analysis 1.2

Comparison 1 Survival, Outcome 2 Pancreatic head carcinoma.

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Analysis 1.3

Comparison 1 Survival, Outcome 3 Periampullary cancer.

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Analysis 2.1

Comparison 2 Mortality, Outcome 1 Postoperative mortality.

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Analysis 3.1

Comparison 3 Pancreatic fistula, Outcome 1 Pancreatic fistula.

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Analysis 4.1

Comparison 4 Delayed gastric emptying (with sensitivity analysis), Outcome 1 All studies.

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Analysis 4.2

Comparison 4 Delayed gastric emptying (with sensitivity analysis), Outcome 2 Studies in which DGE was defined (includes different definitions).

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Analysis 4.3

Comparison 4 Delayed gastric emptying (with sensitivity analysis), Outcome 3 Studies with the same definitions of DGE.

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Analysis 5.1

Comparison 5 Biliary leakage, Outcome 1 Biliary leakage.

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Analysis 6.1

Comparison 6 Intraoperative blood loss, Outcome 1 Intraoperative blood loss (litres).

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Analysis 7.1

Comparison 7 Red blood cell transfusion, Outcome 1 Red blood cell transfusion.

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Analysis 8.1

Comparison 8 Operating time, Outcome 1 Operating time (minutes).

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Analysis 9.1

Comparison 9 Postoperative bleeding, Outcome 1 Postoperative bleeding.

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Analysis 10.1

Comparison 10 Wound infection, Outcome 1 Wound infection.

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Analysis 11.1

Comparison 11 Pulmonary complications, Outcome 1 Pulmonary complications.

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Analysis 12.1

Comparison 12 Necessity for reoperation, Outcome 1 Necessity for reoperation.

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Analysis 13.1

Comparison 13 Hospital stay, Outcome 1 Hospital stay (days).

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Summary of findings for the main comparison. Survival after surgical treatment for periampullary or pancreatic carcinoma

Survival after surgical treatment for periampullary or pancreatic carcinoma
Patient or population: patients with surgical treatment of periampullary or pancreatic carcinoma Settings: Intervention: survival
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	Number of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Control	Survival
Overall survival Follow‐up: 18 to 144 months	Medium‐risk population		HR 0.84 (0.61 to 1.16)	0 (3 studies)	⊕⊕⊝⊝ low^a,b

The basis for the assumed risk* (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; HR: Hazard ratio.
GRADE Working Group grades of evidence. High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
^aInadequate information about sequence generation and allocation concealment. No intention‐to‐treat analysis. ^bVery wide confidence intervals, unknown number of losses to follow‐up, low total number of events, no sample size calculations reported.

Summary of findings for the main comparison. Survival after surgical treatment for periampullary or pancreatic carcinoma

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Summary of findings 2. Mortality after surgical treatment for periampullary or pancreatic carcinoma

Mortality after surgical treatment for periampullary or pancreatic carcinoma
Patient or population: patients with surgical treatment for periampullary and pancreatic carcinoma Settings: Intervention: mortality
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	Number of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Control	Mortality
Postoperative mortality	Study population		OR 0.49 (0.17 to 1.4)	417 (5 studies)	⊕⊕⊝⊝ low^a,b
	52 per 1000	26 per 1000 (9 to 71)
	Medium‐risk population
	44 per 1000	22 per 1000 (8 to 61)
The basis for the assumed risk* (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; OR: Odds ratio.
GRADE Working Group grades of evidence. High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
^aConfidence intervals are wide because of small number of events. No sample size calculation was reported for trials except for Seiler and Tran. ^bPublication bias is unlikely but cannot be excluded. Funnel plotting did not reveal vast asymmetry. However, publication bias cannot be quantified because of the small number of available trials.

Summary of findings 2. Mortality after surgical treatment for periampullary or pancreatic carcinoma

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Summary of findings 3. Intraoperative blood loss in surgical treatment of patients with periampullary or pancreatic carcinoma

Intraoperative blood loss in surgical treatment of patients with periampullary or pancreatic carcinoma
Patient or population: patients with surgical treatment for periampullary or pancreatic carcinoma Settings: Intervention: intraoperative blood loss
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	Number of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Control	Intraoperative blood loss
Intraoperative blood loss (litres)		Mean intraoperative blood loss (litres) in the intervention groups was 0.76 lower (0.96 to 0.56 lower)		33 (1 study)	⊕⊕⊝⊝ low^a,b
The basis for the assumed risk* (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval.
GRADE Working Group grades of evidence. High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
^aSmall number of participants. ^bPublication bias is unlikely but cannot be excluded. Funnel plotting did not reveal vast asymmetry. However, publication bias cannot be quantified because of the small number of available trials.

Summary of findings 3. Intraoperative blood loss in surgical treatment of patients with periampullary or pancreatic carcinoma

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Summary of findings 4. Operating time in surgical treatment for periampullary or pancreatic carcinoma

Operating time in surgical treatment for periampullary or pancreatic carcinoma
Patient or population: patients with surgical treatment for periampullary and pancreatic carcinoma Settings: Intervention: operating time
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	Number of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Control	Operating time
Operating time (minutes)		Mean operating time (minutes) in the intervention groups was 68.26 lower (105.7 to 30.83 lower)		125 (3 studies)	⊕⊕⊝⊝ low^a,b,c
The basis for the assumed risk* (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval.
GRADE Working Group grades of evidence. High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
^aSerious limitations in the study design in the trials of Bloechle, Lin and Wenger are a potential source of bias. All are characterised by small sample sizes, lack of blinding and incomplete outcome reporting. ^bWide confidence intervals indicate significant imprecision of this pooled outcome variable, which causes potential bias. This imbalance in operating time across included trials might be caused by the overall small sample sizes or by unstandardised assessment. ^cPublication bias is unlikely but cannot be excluded. Funnel plotting did not reveal vast asymmetry. However, publication bias cannot be quantified because of the small number of available trials.

Summary of findings 4. Operating time in surgical treatment for periampullary or pancreatic carcinoma

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Comparison 1. Survival

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Overall Show forest plot	3		Hazard ratio (Random, 95% CI)	0.84 [0.61, 1.16]

2 Pancreatic head carcinoma Show forest plot	3		Hazard ratio (Random, 95% CI)	0.73 [0.43, 1.22]

3 Periampullary cancer Show forest plot	2		Hazard ratio (Random, 95% CI)	0.83 [0.39, 1.76]

Comparison 1. Survival

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Comparison 2. Mortality

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Postoperative mortality Show forest plot	5	417	Odds Ratio (M‐H, Random, 95% CI)	0.49 [0.17, 1.40]

Comparison 2. Mortality

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Comparison 3. Pancreatic fistula

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pancreatic fistula Show forest plot	5	421	Odds Ratio (M‐H, Random, 95% CI)	0.86 [0.41, 1.81]

Comparison 3. Pancreatic fistula

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Comparison 4. Delayed gastric emptying (with sensitivity analysis)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 All studies Show forest plot	5	412	Odds Ratio (M‐H, Random, 95% CI)	2.35 [0.72, 7.61]

2 Studies in which DGE was defined (includes different definitions) Show forest plot	3	328	Odds Ratio (M‐H, Random, 95% CI)	1.14 [0.35, 3.68]

3 Studies with the same definitions of DGE Show forest plot	2	198	Odds Ratio (M‐H, Random, 95% CI)	4.02 [0.14, 119.16]

Comparison 4. Delayed gastric emptying (with sensitivity analysis)

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Comparison 5. Biliary leakage

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Biliary leakage Show forest plot	3	333	Odds Ratio (M‐H, Random, 95% CI)	1.35 [0.10, 18.55]

Comparison 5. Biliary leakage

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Comparison 6. Intraoperative blood loss

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Intraoperative blood loss (litres) Show forest plot	1	33	Mean Difference (IV, Random, 95% CI)	‐0.76 [‐0.96, ‐0.56]

Comparison 6. Intraoperative blood loss

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Comparison 7. Red blood cell transfusion

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Red blood cell transfusion Show forest plot	2	79	Mean Difference (IV, Random, 95% CI)	‐0.65 [‐1.92, 0.61]

Comparison 7. Red blood cell transfusion

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Comparison 8. Operating time

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Operating time (minutes) Show forest plot	3	125	Mean Difference (IV, Random, 95% CI)	‐68.26 [‐105.70, ‐30.83]

Comparison 8. Operating time

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Comparison 9. Postoperative bleeding

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Postoperative bleeding Show forest plot	3	333	Odds Ratio (M‐H, Random, 95% CI)	0.74 [0.29, 1.88]

Comparison 9. Postoperative bleeding

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Comparison 10. Wound infection

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Wound infection Show forest plot	4	251	Odds Ratio (M‐H, Random, 95% CI)	0.85 [0.35, 2.05]

Comparison 10. Wound infection

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Comparison 11. Pulmonary complications

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pulmonary complications Show forest plot	3	218	Odds Ratio (M‐H, Random, 95% CI)	0.67 [0.29, 1.58]

Comparison 11. Pulmonary complications

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Comparison 12. Necessity for reoperation

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Necessity for reoperation Show forest plot	2	300	Odds Ratio (M‐H, Random, 95% CI)	0.82 [0.38, 1.75]

Comparison 12. Necessity for reoperation

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Comparison 13. Hospital stay

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Hospital stay (days) Show forest plot	1	48	Mean Difference (IV, Random, 95% CI)	‐1.80 [‐8.94, 5.34]

Comparison 13. Hospital stay

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Referencias

References to studies included in this review

Bloechle 1999 {published data only}

Lin 1999 {published data only}

Paquet 1998 {published data only}

Seiler 2005 {published data only}

Tran 2004 {published data only}

Wenger 1999 {published data only}

References to studies excluded from this review

Bakkevold 1993 {published data only}

Bassi 1994 {published data only}

Bell 2005 {published data only}

Brennan 1994 {published data only}

Buchler 1993 {published data only}

Chou 1996 {published data only}

Farnell 2005 {published data only}

Friess 1996 {published data only}

Johnstone 1993 {published data only}

Nguyen 2003 {published data only}

Pedrazzoli 1998 {published data only}

Seiler 2000 {published data only}

Shan 2003 {published data only}

van Berge Henegouwen {published data only}

Wagner 2004 {published data only}

Yeo 1999 {published data only}

Additional references

Bassi 2001

Bassi 2005a

Bassi 2005b

Buchler 2003

Butturini 2006

DerSimonian 1986

Downs 1998

Edwards 2002

Egger 1997a

Egger 1997b

Fitzsimmons 1998

Gouma 1999

Gouma 2000

GRADE 2008 [Computer program]

Higgins 2005

Jadad 1996

Jemal 2005

Kausch 1912

Kjaergard 2001

Koslowsky 2001

Lillemoe 1996

Lillemoe 2000

Moher 1998

Mosca 1997

Mulrow 1994

Neoptolemos 2001

Parmar 1998

Richter 2003

Roder 1992

Schulz 1995

Sperti 1996

Traverso 1980

Trede 1990

Trede 1993

Watson 1944

Wente 2007

Whipple 1935

Williamson 1993

Yeo 1995

Yeo 1997

References to other published versions of this review

Diener 2007

Diener 2008

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Characteristics of excluded studies [ordered by study ID]

Data and analyses

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Instituciones a las que se accedió previamente

Usuarios institucionales