NCT01189734

Brief Summary

Many options are available for management of common bile duct stones. the most recent development in this field is single-session approach by one of two methods; laparoscopic common bile duct exploration and intraoperative endoscopic sphincterotomy. In this study, the investigators prospectively compare these two methods for management of patients with preoperatively diagnosed common bile duct stones to settle the best option.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
248

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2010

Completed
Last Updated

August 27, 2010

Status Verified

February 1, 2010

First QC Date

August 25, 2010

Last Update Submit

August 26, 2010

Conditions

Common Bile Duct Gallstones

Keywords

common bile duct stoneslaparoscopic common bile duct explorationintraoperative ercpPreoperatively diagnosed common bile duct stones

Outcome Measures

Primary Outcomes (1)

  • success/failure of common bile duct removal

Secondary Outcomes (1)

  • Surgical time

Study Arms (2)

laparoscopic common bile duct exploration

PLACEBO COMPARATOR
Procedure: laparoscopic common bile duct exploration

laparoscopic cholecystectomy with intraoperative ES

ACTIVE COMPARATOR
Procedure: laparoscopic cholecystectomy and intraoperative endoscopic sphincterotomy

Interventions

laparoscopic common bile duct explorationPROCEDURE
laparoscopic common bile duct exploration
laparoscopic cholecystectomy and intraoperative endoscopic sphincterotomyPROCEDURE
laparoscopic cholecystectomy with intraoperative ES

Eligibility Criteria

Age12 Years - 90 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • preoperatively diagnosed common bile duct stones

You may not qualify if:

  • liver cirrhosis pregnancy ASA III, IV Previous abdominal surgery postcholecystectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastroenterology Surgical Center

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Gallstones

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 25, 2010

First Posted

August 27, 2010

Last Updated

August 27, 2010

Record last verified: 2010-02

Locations

EG(1)