Post-ERCP Pancreatitis Prevention by Stent Insertion | NCT01673763

Studies
Post-ERCP Pancreatitis Prevention by Stent Insertion

NCT01673763

Sponsor

Technical University of Munich

Status

Completed

Last Update Posted

Oct 13, 2017Actual

Enrollment

169Actual

Phase

Not Applicable

Conditions

Post-ERCP Acute Pancreatitis

Interventions

Stent insertion into the main pancreatic duct

Countries

Belgium
Germany
Latvia
Russia

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

Oct 2017

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

Jul 2010Actual

Primary Completion Date

Jun 2016Actual

Completion Date

Aug 2017Actual

First Submitted Date

Oct 17, 2011

First Submission Date that Met QC Criteria

Aug 27, 2012

First Posted Date

Aug 28, 2012Estimated

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

Oct 11, 2017

Last Update Posted Date

Oct 13, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Monther Bajbouj, PD Dr. med. Hana Algül, Technical University of MunichPrincipal Investigator

Lead Sponsor

Technical University of MunichOTHER

Collaborators

Name	Class
Northern State University, Russia	UNKNOWN
KU Leuven	OTHER
Latvijas Universitates Medicinas	UNKNOWN

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

The presented study is designed to analyze the efficacy of pancreatic stent insertion in patients undergoing ERCP with accidental cannulation of the pancreatic duct.

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

169Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stent	Active Comparator	Stent insertion into the main pancreatic duct	Device: Stent insertion into the main pancreatic duct
No stent	No Intervention	No stent insertion into the main pancreatic duct

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stent insertion into the main pancreatic duct	Device	Stent insertion into the main pancreatic duct	Stent

Measure	Description	Time Frame
Incidence of post-ERCP pancreatitis		up to 1 week

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all patients undergoing ERCP with unintended cannulation or opifiacation of main pancreatic duct
age > 17 years
signed informed consent

Exclusion Criteria:

intention to intervene main pancreatic duct
age < 18 years
pregnancy
absent of signed informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hana Algül, MD, MPH	II. Medizinische Klinik, Klinikum rechts der Isar, Ismaniger Strasse 22, 81675 Munich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Deptartment of Hepatobiliary Diseases Leuven University Hospitals		Leuven		3000	Belgium
Klinikum rechts der Isar, Technische Universität München

Condition Browse Module

MeSH Terms

ID	Term
D010195	Pancreatitis

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided