Early Versus Late Cholecystectomy After Clearance of Common Bile Duct Stones

NCT ID: NCT02460315

Last Updated: 2015-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2015-04-30

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.

Conditions

Gallbladder and Bile Duct Calculi

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

early cholecystectomy

group (A) will be managed by early laparoscopic cholecystectomy after clearness ERCP

Group Type: ACTIVE_COMPARATOR

early cholecystectomy

Intervention Type: PROCEDURE

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

late cholecystectomy

group (B) will be managed by late LC one month after ERCP.

Group Type: ACTIVE_COMPARATOR

late cholecystectomy

Intervention Type: PROCEDURE

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.

Interventions

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

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

G 1; G 2

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Ayman El Nakeeb

Gastroenterology surgical center, mansoura university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayman El Nakeeb, MD

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

References

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.

Reference Type: RESULT

PMID: 20526779 (View on PubMed)

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.

Reference Type: RESULT

PMID: 12140605 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18270768 (View on PubMed)

Other Identifiers

timing of cholecystectomy

Identifier Type: -

Identifier Source: org_study_id