Laparoscopic‐endoscopic rendezvous versus preoperative endoscopic sphincterotomy in people undergoing laparoscopic cholecystectomy for stones in the gallbladder and bile duct

Nereo Vettoretto; Alberto Arezzo; Federico Famiglietti; Roberto Cirocchi; Lorenzo Moja; Mario Morino

doi:10.1002/14651858.CD010507.pub2

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Figure 1

Study flow diagram

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Figure 2

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 3

Risk of bias graph: review authors' judgements about each risk of bias item presented for each trial

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Figure 4

Trial Sequential Analysis of operating time. DARIS = Pc 49.52%; RRR 20%; alpha 1.6%; beta 20 %; diversity 94%.

The cumulative Z‐curve (blue line) immediately crosses the conventional boundary line. This suggests that there was a difference in the operating time between laparoscopic‐endoscopic rendezvous and preoperative endoscopic sphincterotomy, with a low risk of random error. The horizontal green lines illustrate the conventional level of statistical significance, which was intersected from the first trial. With 313 patients randomised, we had sufficient evidence to accept that preoperative endoscopic sphincterotomy took less operative time than laparoscopic‐endoscopic rendezvous. We used Trial Sequential Analysis software to conduct the analysis and to generate the figure.

Legend: square symbol: Z‐score for single study; diamond symbol: trial sequential monitoring boundary for benefit score for single study.

Abbreviations: DARIS: diversity‐adjusted required information size; Pc: control group proportion observed in the trials; RRR = a relative risk reduction.

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Figure 5

Trial Sequential Analysis of length of hospital stay. DARIS = Pc 50.29%; RRR 20%; alpha 1.6%; beta 20 %; diversity 49%.

The horizontal green lines illustrate the conventional level of statistical significance, which was intersected from the first trial. In the analysis with 515 patients randomised, we had sufficient evidence to accept that laparoscopic‐endoscopic rendezvous resulted in a shorter hospital stay than preoperative endoscopic sphincterotomy. We used Trial Sequential Analysis software to conduct the analysis and to generate the figure.

Legend: square symbol: Z‐score for single study; diamond symbol: trial sequential monitoring boundary for benefit score for single study.

Abbreviations: DARIS: diversity‐adjusted required information size; Pc: control group proportion observed in the trials; RRR = a relative risk reduction.

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Analysis 1.1

Comparison 1 Laparoscopic‐endoscopic rendezvous versus preoperative endoscopic sphincterotomy for common bile duct stones in patients undergoing laparoscopic cholecystectomy, Outcome 1 Overall morbidity (30 days postoperative).

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Analysis 1.2

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Analysis 1.3

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Analysis 1.4

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Analysis 1.5

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Analysis 1.6

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Analysis 1.7

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Analysis 1.8

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Analysis 1.9

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Analysis 1.10

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Summary of findings for the main comparison. Summary of findings in the analysed outcomes

Laparoscopic‐endoscopic rendezvous versus preoperative endoscopic sphincterotomy in people undergoing laparoscopic cholecystectomy for stones in the gallbladder and common bile duct
Population: patients with stones in the gallbladder and common bile duct undergoing laparoscopic cholecystectomy Settings: inpatients Intervention: laparoscopic‐endoscopic rendezvous (LERV) Control: preoperative endoscopic sphincterotomy
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with preoperative endoscopic sphincterotomy	Risk with laparoscopic‐endoscopic rendezvous
Overall mortality (30‐day postoperative; procedure‐ and non‐procedure related)	Study population			516 (5 RCTs)	⊕⊕⊝⊝ LOW ^1,2	Only 1 death in 1 trial reported, in the LERV group
	0 per 1000	0 per 1000 (0 to 0)
Overall morbidity (30‐day postoperative; procedure‐ and non‐procedure related)	Study population		RR 0.59 (0.29 to 1.20)	433 (4 RCTs)	⊕⊕⊝⊝ LOW ^1,3	No trials defined overall morbidity in the methods section.
	142 per 1000	84 per 1000 (41 to 169)
	Moderate
	128 per 1000	75 per 1000 (37 to 152)
Failure of primary clearance	Study population		RR 0.55 (0.22 to 1.38)	516 (5 RCTs)	⊕⊝⊝⊝ VERY LOW ^1,3,4
	131 per 1000	72 per 1000 (29 to 181)
	Moderate
	102 per 1000	56 per 1000 (22 to 141)
Clinical postoperative pancreatitis	Study population		RR 0.31 (0.09 to 1.14)	516 (5 RCTs)	⊕⊕⊝⊝ LOW ^1,3
	73 per 1000	23 per 1000 (7 to 84)
	Moderate
	100 per 1000	31 per 1000 (9 to 114)
Operative time	The mean operative time in the control groups was 88.6 minutes	The mean operative time in the LEVR groups was 34.07 minutes higher (11.41 to 56.74 higher)	MD: 34.07 (11.41 to 56.74)	313 (3 RCTs)	⊕⊝⊝⊝ VERY LOW ^1,3,5	TSA: 23.07 (15.32 to ‐30.81)
Length of hospital stay	The mean length of hospital stay in the control groups was 7.5 days	The mean length of hospital stay in the LEVR groups was 3.01 days shorter (3.51 to 2.5 days shorter)	MD: ‐3.01 (‐3.51 to ‐2.50)	515 (5 RCTs)	⊕⊕⊝⊝ LOW ^1,3	TSA: ‐2.87 (3.66 to ‐2.07)
*The risk in the intervention (LEVR) group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; OR: Odds ratio; RCT: randomised clinical trial; TSA: Trial Sequential Analysis
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Downgraded one level due to risk of bias: high risk of performance and detection bias in all the trials, unclear risk of selection bias in two trials, unclear risk of selective reporting in three trials and high risk in one trial, unclear risk of for‐profit bias in four trials ²Downgraded one level due to imprecision: very low event rate ³Downgraded one level due to imprecision: few trials with few participants ⁴Downgraded one level due to inconsistency: high heterogeneity among trials ( I² = 58%) ⁵Downgraded one level due to inconsistency: very high heterogeneity among trials ( I² = 93%)

Summary of findings for the main comparison. Summary of findings in the analysed outcomes

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Table 1. Events of the composite outcome 'overall morbidity'

Author	Lella 2006	Morino 2006	Rabago 2006	Tzovaras 2012	Sahoo 2014
Hemobilia	NR	X	NR	X	NR
Acute respiratory failure with admission to intensive care unit	NR	X	NR	no	NR
Early incisional hernia	NR	X	NR	no	NR
Bile leak	NR	no	NR	X	NR
Cholangitis	NR	no	NR	X	NR
Bleeding from sphincterotomy	NR	no	NR	X	NR
Bleeding form drain site	NR	no	NR	X	NR
Collection/biloma	NR	no	NR	X	NR
Wound infection	NR	no	NR	X	NR
Urinary retention (UTI)	NR	no	NR	X	NR
Duodenal perforation	X	no	NR	no	X
NR: the authors did not report the type of post‐operative complications X: the authors reported the type of post‐operative complications no: the authors did not report the type of post‐operative complications

Table 1. Events of the composite outcome 'overall morbidity'

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Comparison 1. Laparoscopic‐endoscopic rendezvous versus preoperative endoscopic sphincterotomy for common bile duct stones in patients undergoing laparoscopic cholecystectomy

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Overall morbidity (30 days postoperative) Show forest plot	4	434	Risk Ratio (M‐H, Random, 95% CI)	0.59 [0.29, 1.20]

2 Overall morbidity (30 days postoperative) Show forest plot	4	434	Risk Ratio (M‐H, Fixed, 95% CI)	0.56 [0.32, 0.99]

3 Failure of primary clearance Show forest plot	5	517	Risk Ratio (M‐H, Random, 95% CI)	0.55 [0.22, 1.38]

4 Failure of primary clearance Show forest plot	5	517	Risk Ratio (M‐H, Fixed, 95% CI)	0.61 [0.37, 1.01]

5 Clinical postoperative pancreatitis Show forest plot	5	517	Risk Ratio (M‐H, Random, 95% CI)	0.31 [0.09, 1.14]

6 Clinical postoperative pancreatitis Show forest plot	5	517	Risk Ratio (M‐H, Fixed, 95% CI)	0.28 [0.11, 0.69]

7 Operative time Show forest plot	3	313	Mean Difference (IV, Random, 95% CI)	34.07 [11.41, 56.74]

8 Operative time Show forest plot	3	313	Mean Difference (IV, Fixed, 95% CI)	34.85 [29.34, 40.37]

9 Length of hospital stay Show forest plot	5	515	Mean Difference (IV, Random, 95% CI)	‐3.01 [‐3.51, ‐2.50]

10 Length of hospital stay Show forest plot	5	515	Mean Difference (IV, Fixed, 95% CI)	‐3.00 [‐3.37, ‐2.64]

Comparison 1. Laparoscopic‐endoscopic rendezvous versus preoperative endoscopic sphincterotomy for common bile duct stones in patients undergoing laparoscopic cholecystectomy

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