NCT02460315

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2013

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 2, 2015

Completed
Last Updated

June 2, 2015

Status Verified

May 1, 2013

Enrollment Period

1.9 years

First QC Date

May 22, 2015

Last Update Submit

June 1, 2015

Conditions

Gallbladder and Bile Duct Calculi

Keywords

time of cholecystectomy after ERCP

Outcome Measures

Primary Outcomes (1)

  • conversion rate to open

    number of patients underwent conversion to open

    1 day

Secondary Outcomes (3)

  • signs of inflammation (redness, pus)

    30 days

  • postoperative morbidity

    1 days

  • degree of adhesion (mild,moderate, severe)

    1 days

Study Arms (2)

early cholecystectomy

ACTIVE COMPARATOR

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

Procedure: early cholecystectomy

late cholecystectomy

ACTIVE COMPARATOR

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

Procedure: late cholecystectomy

Interventions

early cholecystectomyPROCEDURE

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

Also known as: G 1
early cholecystectomy
late cholecystectomyPROCEDURE

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.

Also known as: G 2
late cholecystectomy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with CBD stone and treated by ERCP

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 20526779RESULT

  • 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.

    PMID: 12140605RESULT

  • 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.

    PMID: 18270768RESULT

Study Officials

  • Ayman El Nakeeb, MD

    Mansoura University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gastroenterology surgical center, mansoura university

Study Record Dates

First Submitted

May 22, 2015

First Posted

June 2, 2015

Study Start

May 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

June 2, 2015

Record last verified: 2013-05