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

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ClinicalTrials.gov Identifier: NCT01046552
Recruitment Status : Completed
First Posted : January 12, 2010
Last Update Posted : January 12, 2010
Sponsor:
Information provided by:
Mansoura University

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


Condition or disease Intervention/treatment Phase
Common Bile Duct Stones. Procedure: preoperative ERCP and LC Procedure: Intraoperative ERCP and LC Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
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
Study Start Date : June 2006
Actual Primary Completion Date : July 2009
Actual Study Completion Date : September 2009

Arm Intervention/treatment
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




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

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


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Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Older Adult)
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


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

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 Posted: January 12, 2010    Key Record Dates
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