Early Versus Late Cholecystectomy After Clearance of Common Bile Duct Stones (ERCP)

Early Versus Late Cholecystectomy After Clearance of Common Bile Duct Stones by Endoscopic Retrograde Cholangiopancreatography

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.

Study Overview

• Status: Completed
• Conditions: Gallbladder and Bile Duct Calculi
• Intervention / Treatment: Procedure: early cholecystectomy; Procedure: late cholecystectomy

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: early cholecystectomy; group (A) will be managed by early laparoscopic cholecystectomy after clearness ERCP	Procedure: early cholecystectomy; Those patients are primarily managed by endoscopic sphincterotomy and stone extraction for management of CBD stones. Then, the study population will be divided into 2 groups; group 1 will be managed by early laparoscopic cholecystectomy (LC) within 3 days after ERCP; Other Names: G 1
Active Comparator: late cholecystectomy; group (B) will be managed by late LC one month after ERCP.	Procedure: late cholecystectomy; Those patients are primarily managed by endoscopic sphincterotomy and stone extraction for management of CBD stones. Then, the study population will be divided into 2 groups; group 2 will be managed by late LC one month after ERCP.; Other Names: G 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
conversion rate to open	number of patients underwent conversion to open	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
signs of inflammation (redness, pus)	signs of inflammation redness, pus, wall thickness	30 days
postoperative morbidity	postoperative morbidity	1 days
degree of adhesion (mild,moderate, severe)	degree of adhesions	1 days

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Ayman El Nakeeb, MD, Mansoura University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: May 22, 2015
• First Submitted That Met QC Criteria: June 1, 2015
• First Posted (Estimate): June 2, 2015

Study Record Updates

• Last Update Posted (Estimate): June 2, 2015
• Last Update Submitted That Met QC Criteria: June 1, 2015
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: time of cholecystectomy after ERCP
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Calculi
• Other Study ID Numbers: timing of cholecystectomy