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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01046552
First Posted: January 12, 2010
Last Update Posted: January 12, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mansoura University
  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
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Preoperative Versus Intraoperative Endoscopic Sphincterotomy for Management of Choledocholithiasis and Cholecystolithiasis

Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • clearance of stones from the common bile duct [ Time Frame: 6 months ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01046552


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

Additional Information:
Responsible Party: ahmed abdel-raouf el-geidie, gastroenterology surgical center
ClinicalTrials.gov Identifier: NCT01046552     History of Changes
Other Study ID Numbers: ERCP123
First Submitted: January 5, 2010
First Posted: January 12, 2010
Last Update Posted: January 12, 2010
Last Verified: September 2009

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:
Gallstones
Cholelithiasis
Biliary Tract Diseases
Digestive System Diseases
Cholecystolithiasis
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical