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

Sponsor
Mansoura University (Other)
Overall Status
Completed
CT.gov ID
NCT02460315
Collaborator
(none)
50
Enrollment
2
Arms
23
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: early cholecystectomy
  • Procedure: late cholecystectomy
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Early Versus Late Cholecystectomy After Clearance of Common Bile Duct Stones by Endoscopic Retrograde Cholangiopancreatography
Study Start Date :
May 1, 2013
Actual Primary Completion Date :
Apr 1, 2015
Actual Study Completion Date :
Apr 1, 2015

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. conversion rate to open [1 day]

      number of patients underwent conversion to open

    Secondary Outcome Measures

    1. signs of inflammation (redness, pus) [30 days]

      signs of inflammation redness, pus, wall thickness

    2. postoperative morbidity [1 days]

      postoperative morbidity

    3. degree of adhesion (mild,moderate, severe) [1 days]

      degree of adhesions

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Mansoura University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ayman El Nakeeb, Gastroenterology surgical center, mansoura university, Mansoura University
    ClinicalTrials.gov Identifier:
    NCT02460315
    Other Study ID Numbers:
    • timing of cholecystectomy
    First Posted:
    Jun 2, 2015
    Last Update Posted:
    Jun 2, 2015
    Last Verified:
    May 1, 2013
    Keywords provided by Ayman El Nakeeb, Gastroenterology surgical center, mansoura university, Mansoura University
    time of cholecystectomy after ERCP
    Additional relevant MeSH terms:
    Calculi

    Study Results

    No Results Posted as of Jun 2, 2015