NCT01190332

Brief Summary

One of the new methods for management of common bile duct stones is intraoperative endoscopic sphincterotomy. It can be performed by many techniques. In the study the investigators compare two methods to find out the best technique for intraoperative endoscopic sphincterotomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2007

Typical duration 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

October 1, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 27, 2010

Completed
Last Updated

August 27, 2010

Status Verified

February 1, 2010

Enrollment Period

2.3 years

First QC Date

July 6, 2010

Last Update Submit

August 26, 2010

Conditions

Common Bile Duct Gallstones

Keywords

common bile duct stones

Outcome Measures

Primary Outcomes (1)

  • success/failure rate of common bile duct stones removal

Secondary Outcomes (1)

  • complication rate

Study Arms (2)

conventional technique of ERCP

PLACEBO COMPARATOR
Procedure: endoscopic sphincterotomy by conventional method

Rendezvous technique

ACTIVE COMPARATOR
Procedure: endoscopic sphincterotomy by rendezvous method

Interventions

endoscopic sphincterotomy by conventional methodPROCEDURE
conventional technique of ERCP
endoscopic sphincterotomy by rendezvous methodPROCEDURE
Rendezvous technique

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with MRCP evidence of common bile duct stones

You may not qualify if:

  • cholangitis pancreatitis ASA GRADE III, IV Unfit for laparoscopy unfit for ERCP

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

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

July 6, 2010

First Posted

August 27, 2010

Study Start

October 1, 2007

Primary Completion

February 1, 2010

Study Completion

March 1, 2010

Last Updated

August 27, 2010

Record last verified: 2010-02

Locations

EG(1)