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

Primary Purpose

Gallbladder and Bile Duct Calculi

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
early cholecystectomy
late cholecystectomy
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gallbladder and Bile Duct Calculi focused on measuring time of cholecystectomy after ERCP

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    early cholecystectomy

    late cholecystectomy

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    conversion rate to open
    number of patients underwent conversion to open

    Secondary Outcome Measures

    signs of inflammation (redness, pus)
    signs of inflammation redness, pus, wall thickness
    postoperative morbidity
    postoperative morbidity
    degree of adhesion (mild,moderate, severe)
    degree of adhesions

    Full Information

    First Posted
    May 22, 2015
    Last Updated
    June 1, 2015
    Sponsor
    Mansoura University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02460315
    Brief Title
    Early Versus Late Cholecystectomy After Clearance of Common Bile Duct Stones
    Acronym
    ERCP
    Official Title
    Early Versus Late Cholecystectomy After Clearance of Common Bile Duct Stones by Endoscopic Retrograde Cholangiopancreatography
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2013 (undefined)
    Primary Completion Date
    April 2015 (Actual)
    Study Completion Date
    April 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mansoura University

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gallbladder and Bile Duct Calculi
    Keywords
    time of cholecystectomy after ERCP

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    early cholecystectomy
    Arm Type
    Active Comparator
    Arm Description
    group (A) will be managed by early laparoscopic cholecystectomy after clearness ERCP
    Arm Title
    late cholecystectomy
    Arm Type
    Active Comparator
    Arm Description
    group (B) will be managed by late LC one month after ERCP.
    Intervention Type
    Procedure
    Intervention Name(s)
    early cholecystectomy
    Other Intervention Name(s)
    G 1
    Intervention Description
    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
    Intervention Name(s)
    late cholecystectomy
    Other Intervention Name(s)
    G 2
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    conversion rate to open
    Description
    number of patients underwent conversion to open
    Time Frame
    1 day
    Secondary Outcome Measure Information:
    Title
    signs of inflammation (redness, pus)
    Description
    signs of inflammation redness, pus, wall thickness
    Time Frame
    30 days
    Title
    postoperative morbidity
    Description
    postoperative morbidity
    Time Frame
    1 days
    Title
    degree of adhesion (mild,moderate, severe)
    Description
    degree of adhesions
    Time Frame
    1 days

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ayman El Nakeeb, MD
    Organizational Affiliation
    Mansoura University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20526779
    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.
    Results Reference
    result
    PubMed Identifier
    12140605
    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.
    Results Reference
    result
    PubMed Identifier
    18270768
    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.
    Results Reference
    result

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    Early Versus Late Cholecystectomy After Clearance of Common Bile Duct Stones

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