Endoscopic balloon sphincter dilation (sphincteroplasty) versus sphincterotomy for common bile duct stones

Benjamin Weinberg; Waleed Shindy; Simon Lo

doi:10.1002/14651858.CD004890.pub2

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Analysis 1.1

Comparison 1 Primary outcomes (Technical success), Outcome 1 Stone removal on 1st attempt.

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Analysis 1.2

Comparison 1 Primary outcomes (Technical success), Outcome 2 Stone recurrence overall.

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Analysis 2.1

Comparison 2 Primary adverse event outcomes, Outcome 1 Mortality.

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Analysis 2.2

Comparison 2 Primary adverse event outcomes, Outcome 2 Total pancreatitis.

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Analysis 2.3

Comparison 2 Primary adverse event outcomes, Outcome 3 Bleeding.

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Analysis 2.4

Comparison 2 Primary adverse event outcomes, Outcome 4 Perforation.

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Analysis 2.5

Comparison 2 Primary adverse event outcomes, Outcome 5 Cholangitis.

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Analysis 2.6

Comparison 2 Primary adverse event outcomes, Outcome 6 Cholecystitis.

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Analysis 2.7

Comparison 2 Primary adverse event outcomes, Outcome 7 Nonbiliar infection.

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Analysis 2.8

Comparison 2 Primary adverse event outcomes, Outcome 8 Total Infections.

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Analysis 2.9

Comparison 2 Primary adverse event outcomes, Outcome 9 Total primary short‐term complications.

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Analysis 3.2

Comparison 3 Secondary adverse event outcomes, Outcome 2 Total secondary adverse events.

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Analysis 3.3

Comparison 3 Secondary adverse event outcomes, Outcome 3 Total overall short‐term complications.

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Analysis 4.1

Comparison 4 Other secondary outcomes, Outcome 1 Long‐term cholangitis.

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Analysis 4.2

Comparison 4 Other secondary outcomes, Outcome 2 Long‐term acute cholecystitis.

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Analysis 4.3

Comparison 4 Other secondary outcomes, Outcome 3 Total long‐term infections.

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Analysis 4.4

Comparison 4 Other secondary outcomes, Outcome 4 Total long‐term complications.

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Analysis 5.1

Comparison 5 Post hoc analysis, Outcome 1 Overall success rate (w/repeated procedure).

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Analysis 5.2

Comparison 5 Post hoc analysis, Outcome 2 Repeated same procedure.

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Analysis 5.3

Comparison 5 Post hoc analysis, Outcome 3 Switched to different procedure.

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Analysis 5.4

Comparison 5 Post hoc analysis, Outcome 4 Stone removal requiring mechanical lithotripsy.

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Table 1. Data abstraction form

Database

Attempts will be made to abstract the items listed below from each trial. When possible the total number, percentage, mean, and standard deviation will be recorded for patients within the sphincteroplasty and sphincterotomy groups.

Abstractor
Date abstracted
Study author
Center
Study date (Year)
Total number of patients
Age
Gender
Country of study
Size of biliary tract stones
Number of biliary tract stones
Length of balloon dilation (time)
Diameter of balloon dilation
Overall success rate
Success (removal 1st attempt)
Treatment failure (repeat procedure)
Treatment failure (different procedure)
Overall success rate (stones < 10 mm)
Success 1st attempt (stones < 10 mm)
Overall success rate (stones > 10 mm)
Success 1st attempt (stones > 10 mm)
Number of balloon dilations
Demonstration of ductal clearance
Lithotripsy (0verall)
Lithotripsy (stones >10 mm)
Number of procedures required for stone removal
Preprocedure antibiotics
Stone recurrence (list time as well)
Bile duct diameter
Length of cut
Duration of procedure
Length of stay
Sphincterotomy cut current/type
Mortality
Pancreatitis (grade)
Bleeding
Perforation
Infection (cholangitis)
Infection (non‐cholangitis)
Cholecystitis
PNA
Other adverse effects
Total primary short term adverse events
Total overall short term adverse events
Pancreatic duct stenting
Need for lithotripsy
Cost
Length of follow‐up
Use of prophylatic pancreatitis meds (list name)
Level of endoscopist
Allocation concealment
Blinding
Intention to treat
Long term complications (LTC) (papillary stenosis)
LTC (loss sphincter tone more than six months)
LTC (bacterial contamination of biliary tree)
LTC (bile duct maligancy)
LTC (other and list type)
Total LTC
Pre‐existing coagulopathy (type)
Abnormal anatomy (list types and numbers)

Table 1. Data abstraction form

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Comparison 1. Primary outcomes (Technical success)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Stone removal on 1st attempt Show forest plot	7	786	Risk Ratio (M‐H, Random, 95% CI)	0.90 [0.84, 0.97]

2 Stone recurrence overall Show forest plot	7	875	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.57, 1.64]

Comparison 1. Primary outcomes (Technical success)

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Comparison 2. Primary adverse event outcomes

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Mortality Show forest plot	7	1197	Risk Ratio (M‐H, Fixed, 95% CI)	1.61 [0.43, 6.06]

2 Total pancreatitis Show forest plot	14	1664	Risk Ratio (M‐H, Fixed, 95% CI)	1.98 [1.35, 2.90]

3 Bleeding Show forest plot	12	1363	Risk Ratio (M‐H, Random, 95% CI)	0.15 [0.06, 0.39]

4 Perforation Show forest plot	9	1185	Risk Ratio (M‐H, Fixed, 95% CI)	0.78 [0.17, 3.46]

5 Cholangitis Show forest plot	7	967	Odds Ratio (M‐H, Fixed, 95% CI)	0.86 [0.39, 1.89]

5.1 Cholangitis	7	967	Odds Ratio (M‐H, Fixed, 95% CI)	0.86 [0.39, 1.89]
6 Cholecystitis Show forest plot	6	1049	Odds Ratio (M‐H, Random, 95% CI)	0.29 [0.12, 0.68]

6.1 Cholecystitis	6	1049	Odds Ratio (M‐H, Random, 95% CI)	0.29 [0.12, 0.68]
7 Nonbiliar infection Show forest plot	2	174	Odds Ratio (M‐H, Fixed, 95% CI)	1.14 [0.14, 9.21]

7.1 Non biliary	2	174	Odds Ratio (M‐H, Fixed, 95% CI)	1.14 [0.14, 9.21]
8 Total Infections Show forest plot	14	1581	Risk Ratio (M‐H, Random, 95% CI)	0.55 [0.31, 0.96]

9 Total primary short‐term complications Show forest plot	15	1768	Risk Ratio (M‐H, Random, 95% CI)	1.01 [0.62, 1.63]

Comparison 2. Primary adverse event outcomes

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Comparison 3. Secondary adverse event outcomes

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Other adverse effects	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2 Total secondary adverse events Show forest plot	6	999	Odds Ratio (M‐H, Fixed, 95% CI)	1.24 [0.61, 2.50]

3 Total overall short‐term complications Show forest plot	15	1768	Risk Ratio (M‐H, Fixed, 95% CI)	0.96 [0.75, 1.23]

Comparison 3. Secondary adverse event outcomes

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Comparison 4. Other secondary outcomes

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Long‐term cholangitis Show forest plot	2	312	Risk Ratio (M‐H, Random, 95% CI)	1.29 [0.29, 5.78]

1.1 Cholangitis	2	312	Risk Ratio (M‐H, Random, 95% CI)	1.29 [0.29, 5.78]
2 Long‐term acute cholecystitis Show forest plot	6	764	Odds Ratio (M‐H, Random, 95% CI)	0.29 [0.10, 0.81]

2.1 Acute cholecystitis	6	764	Odds Ratio (M‐H, Random, 95% CI)	0.29 [0.10, 0.81]
3 Total long‐term infections Show forest plot	6	764	Risk Ratio (M‐H, Fixed, 95% CI)	0.44 [0.21, 0.91]

4 Total long‐term complications Show forest plot	7	868	Risk Ratio (M‐H, Random, 95% CI)	0.72 [0.50, 1.03]

Comparison 4. Other secondary outcomes

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Comparison 5. Post hoc analysis

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Overall success rate (w/repeated procedure) Show forest plot	13	1620	Risk Ratio (M‐H, Random, 95% CI)	0.96 [0.94, 0.98]

2 Repeated same procedure Show forest plot	6	844	Risk Ratio (M‐H, Random, 95% CI)	1.06 [0.82, 1.37]

3 Switched to different procedure Show forest plot	9	1246	Risk Ratio (M‐H, Random, 95% CI)	8.29 [3.28, 21.00]

4 Stone removal requiring mechanical lithotripsy Show forest plot	13	1735	Risk Ratio (M‐H, Random, 95% CI)	1.34 [1.08, 1.66]

Comparison 5. Post hoc analysis

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