Clinical outcomes in patients with bile leaks treated via ERCP with regard to the timing of ERCP: a large multicenter study.

Background And Aims: Postsurgical or traumatic bile duct leaks (BDLs) can be safely and effectively managed by endoscopic therapy via ERCP. The early diagnosis of BDL is important because unrecognized leaks can lead to serious adverse events (AEs). Our aim was to evaluate the relationship between timing of endotherapy after BDL and the clinical outcomes, AEs, and long-term results of endoscopic therapy.

Methods: We conducted a multicenter, retrospective study on patients with BDLs who underwent ERCP between 2006 and 2014. Data were assembled on patient demographics, etiology of BDL, and procedural details. Endotherapy for BDLs were classified a priori into 3 groups based on timing of ERCP from time of biliary injury: within 1 day of BDL, on day 2 or 3 after BDL, and greater than 3 days after BDL. The relationship among timing of ERCP after BDL injury and outcomes, procedure-related AEs, and patient AEs and mortality were evaluated.

Results: From February 2006 to June 2014, 518 patients (50% male; mean age, 51.7 years) underwent ERCP for therapy of BDLs. The etiology of the BDL was laparoscopic cholecystectomy (70.7%), post-liver transplantation (11.2%), liver resection (14.1%), trauma (2.5%), and other causes (1.5%). Endotherapy was performed by placing a transpapillary stent alone (73.5%) or with a sphincterotomy (26.5%). The timing of ERCPs was as follows: ≤1 day = 57 patients, day 2 or 3 = 140 patients, and >3 days = 321 patients. There was no statistical difference in patient demographics, etiology/site of BDL, or type of endotherapy performed among the 3 groups. On multivariate analysis there was no statistically significant difference in BDL success rate for ERCPs performed within 1 day compared with those performed on day 2 or 3 or after 3 days of bile duct injury (91.2%, 90%, and 88.5%, respectively; P = .77). Similarly, there was no significant difference in the overall patient AE rate among the 3 groups (21.1%, 22.9%, and 24.6%, respectively; P = .81). AEs in men occurred significantly more frequently when compared with women, even after adjusting for age, BDL etiology, and location of leak (27.6% vs 19.9%; OR, 1.53; P = .04). Patients whose BDL was due to a cholecystectomy had a lower AE and mortality rate compared with those who had biliary injury from other etiologies (OR, .42; P < .001).

Conclusions: The overall success rates and AEs after ERCP were not dependent on the timing of the procedure relative to the discovery of the bile leak. This suggests that ERCP in these patients can usually be performed in an elective, rather than an urgent, manner.