Clinical trial NCT02460315: Early Versus Late Cholecystectomy After Clearance of Common Bile Duct Stones
Official title: Early Versus Late Cholecystectomy After Clearance of Common Bile Duct Stones by Endoscopic Retrograde Cholangiopancreatography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gallbladder and Bile Duct Calculi
Keywords: time of cholecystectomy after ERCP
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-06-02
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Approximately 10-15% of all patients with gallstones have coexisting common bile duct (CBD) stones. However CBD stones can also be formed in the absence of gallbladder stones. The current standard of treatment for calcular obstructive jaundice is endoscopic removal of the stones. Endoscopic sphincterotomy (ES) is widely accepted as the treatment of choice for patients with CBDS. Stone extraction is successful in up to 97% of patients The time interval between ERCP and laparoscopic cholecystectomy (LC) is a matter of debate that may vary from days to months. Some retrospective and other prospective studies have investigated this issue without sharp clue or definite conclusion This study planned to compare early LC (within admission) versus late LC (after 1 month) after ERCP as regard technical difficulties and surgical outcomes.

Detailed description: The aim is comparing early versus delayed laparoscopic cholecystectomy after endoscopic retrograde cholangiopancreatography in patients with gall bladder stones and calcular obstructive jaundice as regards operative difficulties, conversion rate, signs of inflammation, degree of adhesions, blood loss, postoperative morbidity, and hospital stay. Moreover, bacterial examination of bile and culture sensitivity test for assessment of bacterial colonization and relate the degree of colonization to timing of laparoscopic cholecystectomy after endoscopic retrograde cholangiopancreatography, to decide upon the optimal timing for the surgery.

The study population will be divided into 2 groups; group (A) will be managed by early laparoscopic cholecystectomy (LC) within 3 days after ERCP and group (B) will be managed by late LC one month after ERCP.

Eligibility criteria: Inclusion Criteria:

* Patients with CBD stone and treated by ERCP

Exclusion Criteria:

* Patient unfit for surgery,
* Pregnant patients,
* Patients with severe malnutrition,
* Patients with liver cirrhosis,
* Patients in whom endoscopic management of CBD stones failed
* Patients who experienced pancreatitis or perforation as a complication of the endoscopic management of CBD stones
* Patients who underwent previous upper abdominal surgeries
* Mentally retarded patients.

Primary outcomes:
measure: conversion rate to open
timeFrame: 1 day
Secondary outcomes:
measure: signs of inflammation (redness, pus)
timeFrame: 30 days
measure: postoperative morbidity
timeFrame: 1 days
measure: degree of adhesion (mild,moderate, severe)
timeFrame: 1 days
Other outcomes:
Locations:
Study officials:
affiliation: Mansoura University
name: Ayman El Nakeeb, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bostanci EB, Ercan M, Ozer I, Teke Z, Parlak E, Akoglu M. Timing of elective laparoscopic cholecystectomy after endoscopic retrograde cholangiopancreaticography with sphincterotomy: a prospective observational study of 308 patients. Langenbecks Arch Surg. 2010 Aug;395(6):661-6. doi: 10.1007/s00423-010-0653-y. Epub 2010 Jun 6.
citation: Mo LR, Chang KK, Wang CH, Yau MP, Yang TM. Preoperative endoscopic sphincterotomy in the treatment of patients with cholecystocholedocholithiasis. J Hepatobiliary Pancreat Surg. 2002;9(2):191-5. doi: 10.1007/s005340200017.
citation: Schiphorst AH, Besselink MG, Boerma D, Timmer R, Wiezer MJ, van Erpecum KJ, Broeders IA, van Ramshorst B. Timing of cholecystectomy after endoscopic sphincterotomy for common bile duct stones. Surg Endosc. 2008 Sep;22(9):2046-50. doi: 10.1007/s00464-008-9764-8. Epub 2008 Feb 13.