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

This study has been completed.
Sponsor:
Information provided by:
Mansoura University
ClinicalTrials.gov Identifier:
NCT01046552
First received: January 5, 2010
Last updated: January 11, 2010
Last verified: September 2009
History of Changes
  Purpose

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


Condition Intervention
Common Bile Duct Stones.
 Procedure: preoperative ERCP and LC
Procedure: Intraoperative ERCP and LC

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Preoperative Versus Intraoperative Endoscopic Sphincterotomy for Management of Choledocholithiasis and Cholecystolithiasis

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy Gallstones
U.S. FDA Resources

Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • clearance of stones from the common bile duct [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • bile duct injuries, retained stones, hospital stay, surgical time, conversion to open cholecystectomy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 210
Study Start Date: June 2006
Study Completion Date: September 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PES/LC
preoperative ES followed by LC within the same hospital admission
 Procedure: preoperative ERCP and LC
preoperative ERCP followed by LC
Active Comparator: LC/IOES
laparoscopic cholecystectomy with intraoperative ercp under the same anesthesia
 Procedure: Intraoperative ERCP and LC
LC and intraoperative ERCP

  Eligibility

Ages Eligible for Study:   12 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with gallstones and common bile duct stones

Exclusion Criteria:

  • contraindications to ercp

contraindication to laparoscopy

biliary pancreatitis

refusal to participate

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01046552

Locations
Egypt
Ahmed Abdel-Raouf El-Geidie
Mansoura, Dakahlia, Egypt, 35516
Sponsors and Collaborators
Mansoura University
  More Information

No publications provided

Responsible Party: ahmed abdel-raouf el-geidie, gastroenterology surgical center
ClinicalTrials.gov Identifier: NCT01046552     History of Changes
Other Study ID Numbers: ERCP123
Study First Received: January 5, 2010
Last Updated: January 11, 2010
Health Authority: Egypt: Institutional Review Board

Keywords provided by Mansoura University:
Choledocholithias
Common bile duct stones
Endoscopic retrograde cholangiopancreatography
endoscopic sphincterotomy
 Preoperative
intraoperative
Laparoscopic common bile duct exploration

Additional relevant MeSH terms:
Calculi
Cholecystolithiasis
Gallstones
Choledocholithiasis
Pathological Conditions, Anatomical
Cholelithiasis
 Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Common Bile Duct Diseases
Bile Duct Diseases

ClinicalTrials.gov processed this record on May 23, 2013