ERC Via Double-Balloon-Enteroscopy in Patients With Bilio... | NCT00454129

Studies
ERC Via Double-Balloon-Enteroscopy in Patients With Biliodigestive Anastomosis

NCT00454129

Sponsor

Heidelberg University

Status

Unknown status

Last Update Posted

Jan 28, 2013Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Cholangiography

Interventions

cholangiography via double-balloon enteroscopy
MR cholangiography

Countries

Germany

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

Mar 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Mar 29, 2007

First Submission Date that Met QC Criteria

Mar 29, 2007

First Posted Date

Mar 30, 2007Estimated

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 25, 2013

Last Update Posted Date

Jan 28, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

In patients with biliodigestive anastomosis direct cholangiography (ERC) is due to changed anatomy commonly not possible. The aim of the study is to test the feasibility to perform direct cholangiography in these patients via double-balloon enteroscopy and to compare it to MR cholangiography.

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

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Biliodigestive anastomosis; and
Suspicion of biliary disorder

Exclusion Criteria:

Exclusion criteria of double-balloon enteroscopy and MR-cholangiography

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jens Encke, Prof.	Contact	+49-6221-568611		jens_encke@med.uni-heidelberg.de

Overall Officials

Name	Affiliation	Role
Jens Encke, Prof.	Medical University of Heidelberg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Heidelberg, Department of Gastroenterology	Recruiting	Heidelberg		69120	Germany

Name	Type	Description	Arm Group Labels	Other Names
cholangiography via double-balloon enteroscopy	Procedure
MR cholangiography	Procedure