NCT01046552

Brief Summary

ERCP plays an important role in management of common bile duct stones. Herein the investigators compare preoperative against intraoperative ERCP. 210 were included but only 198 patients were randomly divided into two groups; PES/LC (100 patients) and LC/IOES (98 patients). The total hospital stay were significantly shorter in the group of LC/IOES

Trial Health

87
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2006

Longer than 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 12, 2010

Completed
Last Updated

January 12, 2010

Status Verified

September 1, 2009

Enrollment Period

3.1 years

First QC Date

January 5, 2010

Last Update Submit

January 11, 2010

Conditions

Common Bile Duct Stones.

Keywords

CholedocholithiasCommon bile duct stonesEndoscopic retrograde cholangiopancreatographyendoscopic sphincterotomyPreoperativeintraoperativeLaparoscopic common bile duct exploration

Outcome Measures

Primary Outcomes (1)

  • clearance of stones from the common bile duct

    6 months

Secondary Outcomes (1)

  • bile duct injuries, retained stones, hospital stay, surgical time, conversion to open cholecystectomy

    6 months

Study Arms (2)

PES/LC

ACTIVE COMPARATOR

preoperative ES followed by LC within the same hospital admission

Procedure: preoperative ERCP and LC

LC/IOES

ACTIVE COMPARATOR

laparoscopic cholecystectomy with intraoperative ercp under the same anesthesia

Procedure: Intraoperative ERCP and LC

Interventions

preoperative ERCP and LCPROCEDURE

preoperative ERCP followed by LC

PES/LC
Intraoperative ERCP and LCPROCEDURE

LC and intraoperative ERCP

LC/IOES

Eligibility Criteria

Age12 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with gallstones and common bile duct stones

You may not qualify if:

  • contraindications to ercp
  • contraindication to laparoscopy
  • biliary pancreatitis
  • refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abdel-Raouf El-Geidie

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

Related Links

Study Design

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

Study Record Dates

First Submitted

January 5, 2010

First Posted

January 12, 2010

Study Start

June 1, 2006

Primary Completion

July 1, 2009

Study Completion

September 1, 2009

Last Updated

January 12, 2010

Record last verified: 2009-09

Locations

EG(1)