Comparison Between Pre and Intraoperative ERCP in Treatme... | NCT01046552

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

NCT01046552

Sponsor

Mansoura University

Status

Completed

Last Update Posted

Jan 12, 2010Estimated

Enrollment

210Actual

Phase

Not Applicable

Conditions

Common Bile Duct Stones.

Interventions

preoperative ERCP and LC
Intraoperative ERCP and LC

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

Sep 2009

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

Jun 2006

Primary Completion Date

Jul 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Jan 5, 2010

First Submission Date that Met QC Criteria

Jan 11, 2010

First Posted Date

Jan 12, 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

Jan 11, 2010

Last Update Posted Date

Jan 12, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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

210Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PES/LC	Active Comparator	preoperative ES followed by LC within the same hospital admission	Procedure: preoperative ERCP and LC
LC/IOES	Active Comparator	laparoscopic cholecystectomy with intraoperative ercp under the same anesthesia	Procedure: Intraoperative ERCP and LC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
preoperative ERCP and LC	Procedure	preoperative ERCP followed by LC	PES/LC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
clearance of stones from the common bile duct		6 months

Secondary Outcomes

Measure	Description	Time Frame
bile duct injuries, retained stones, hospital stay, surgical time, conversion to open cholecystectomy		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with gallstones and common bile duct stones

Exclusion Criteria:

contraindications to ercp

contraindication to laparoscopy

biliary pancreatitis

refusal to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder 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
Ahmed Abdel-Raouf El-Geidie		Al Mansurah	Dakahlia Governorate	35516	Egypt