Conventional Versus Rendezvous Technique of Intraoperativ... | NCT01190332

Studies
Conventional Versus Rendezvous Technique of Intraoperative Endoscopic Retrograde Cholangiopancreatography

NCT01190332

Sponsor

Mansoura University

Status

Completed

Last Update Posted

Aug 27, 2010Estimated

Enrollment

98Actual

Phase

Not Applicable

Conditions

Common Bile Duct Gallstones

Interventions

endoscopic sphincterotomy by conventional method
endoscopic sphincterotomy by rendezvous method

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Feb 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Jul 6, 2010

First Submission Date that Met QC Criteria

Aug 26, 2010

First Posted Date

Aug 27, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 26, 2010

Last Update Posted Date

Aug 27, 2010Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

98Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
conventional technique of ERCP	Placebo Comparator		Procedure: endoscopic sphincterotomy by conventional method
Rendezvous technique	Active Comparator		Procedure: endoscopic sphincterotomy by rendezvous method

Interventions

Name	Type	Description	Arm Group Labels	Other Names
endoscopic sphincterotomy by conventional method	Procedure		conventional technique of ERCP
endoscopic sphincterotomy by rendezvous method

Measure	Description	Time Frame
success/failure rate of common bile duct stones removal

Measure	Description	Time Frame
complication rate

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with MRCP evidence of common bile duct stones

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gastroenterology Surgical Center		Al Mansurah	Dakahlia Governorate	35516	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D042882	Gallstones

Ancestor Terms

ID	Term
D002769	Cholelithiasis
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases
D041761	Cholecystolithiasis

Browse Leaves

Not provided

Browse Branches

Not provided