NCT01673763

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2011

Completed
11 months until next milestone

First Posted

Study publicly available on registry

August 28, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

5.9 years

First QC Date

October 17, 2011

Last Update Submit

October 11, 2017

Conditions

Post-ERCP Acute Pancreatitis

Keywords

ERCPendoscopypancreatitis

Outcome Measures

Primary Outcomes (1)

  • Incidence of post-ERCP pancreatitis

    up to 1 week

Study Arms (2)

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

Stent insertion into the main pancreatic ductDEVICE

Stent insertion into the main pancreatic duct

Stent

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Deptartment of Hepatobiliary Diseases Leuven University Hospitals

Leuven, 3000, Belgium

Location

Klinikum rechts der Isar, Technische Universität München

Munich, 81675, Germany

Location

P. Stradin Clinical University Hospital Gastroenterology Centere Latvijas Universitates Medicinas

Riga, 1002, Latvia

Location

First city hospital of emergency care Northern State Medical University

Arkhangelsk, 163045, Russia

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Officials

  • Hana Algül, MD, MPH

    II. Medizinische Klinik, Klinikum rechts der Isar, Ismaniger Strasse 22, 81675 Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med. Hana Algül

Study Record Dates

First Submitted

October 17, 2011

First Posted

August 28, 2012

Study Start

July 1, 2010

Primary Completion

June 1, 2016

Study Completion

August 1, 2017

Last Updated

October 13, 2017

Record last verified: 2017-10

Locations

BE(1)DE(1)LA(1)RU(1)