The Need for Repeat ERCP After Endoscopic Treatment of Postsurgical Biliary Leaks

Condition(s) studied

Investigational drug(s) / intervention(s)

Endoscopic Retrograde Cholangiopancreatography (ERCP): Endoscopic procedure employed to manage biliary and pancreatic diseases

Study summary

Post-surgical biliary leaks are relatively common after surgeries associated with hepatobiliary health. Left untreated, biliary leaks can lead to significant morbidity. Biliary leaks are most often successfully managed endoscopically, by way of performing an ERCP (endoscopic retrograde cholangio-pancreatography) procedure. These procedures help manage the bile leak by decreasing pressure at the opening of the common bile duct and promoting bile flow into the small bowel (rather than out the leak) via stent insertion.

Guidelines published by the American Society for Gastrointestinal Endoscopy (ASGE) report that stents are generally placed for 4 to 6 weeks and recommend longer intervals for more complex leaks. However, formal recommendations concerning the modality of biliary stent removal do not exist.

One option is performing a repeat ERCP when removing the stent. While comprehensive, this exposes the patient to additional radiation, and requires additional fluoroscopy resources and/or technicians. Furthermore, ERCPs are less available, especially in smaller centers, and are costly. A second option is a gastroscopy with simple stent removal has, given the low probability of requiring repeat intervention, the relatively low procedural cost, and the relatively favorable adverse event profile, and easier accessibility compared to ERCP procedures.

A simple, safe and reliable prediction rule was developed retrospectively to identify patients in whom biliary stent removal via gastroscopy could be safely performed, as opposed to repeat ERCP. A positive result using the rule requires satisfaction of four non-invasive clinical markers: (1) a normal post-surgical serum alkaline phosphatase value, (2) bile leak 'type C' at initial ERCP (a small or absent leak with no other biliary pathology), (3) a bile leak caused by laparoscopic cholecystectomy, and (4) a time between initial and follow-up endoscopy of 4 to 8 weeks. Validating this prediction rule prospectively could have implications on patient safety by decreasing ERCP-related adverse events, and could also have important implications with regard to health resource utilization.

Eligibility

Primary outcome measure(s)

• Absence of persistent bile leak — immediate
  On repeat endoscopic evaluation absence of persistent bile leak or additional pathology will be evaluated

Trial sites (1)

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