Comparison Between Pre and Intraoperative ERCP in Treatment of Common Bile Duct Stones

Common Bile Duct Stones. Clinical Trial

Official title:

Preoperative Versus Intraoperative Endoscopic Sphincterotomy for Management of Choledocholithiasis and Cholecystolithiasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01046552
• Other study ID #: ERCP123
• Status: Completed
• Phase: N/A
• First received: January 5, 2010
• Last updated: January 11, 2010
• Start date: June 2006
• Est. completion date: September 2009

Study information

• Verified date: September 2009
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: September 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients with gallstones and common bile duct stones

Exclusion Criteria:

• contraindications to ercp

contraindication to laparoscopy

biliary pancreatitis

refusal to participate

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Common Bile Duct Stones.
• Gallstones

Intervention

Procedure:
• preoperative ERCP and LC
preoperative ERCP followed by LC
• Intraoperative ERCP and LC
LC and intraoperative ERCP

Locations

Country	Name	City	State
Egypt	Ahmed Abdel-Raouf El-Geidie	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clearance of stones from the common bile duct		6 months	Yes
Secondary	bile duct injuries, retained stones, hospital stay, surgical time, conversion to open cholecystectomy		6 months	Yes

External Links

•   mansoura university