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
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
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
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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