Sonographic Detection of Prophylactic Pancreatic Stents

April 21, 2020 updated by: Georg Dultz, Johann Wolfgang Goethe University Hospital

Sonographic Detection of Pancreatic Stents Placed for Prophylaxis of Post-ERCP Pancreatitis

The Retention of pancreatic stents for prophylaxis of post-ERCP pancreatitis (PEP) is assessed by abdominal x-ray according to international Guidelines. The current study aimed to analyze whether prophylactic pancreatic stents can be detected by transdermal ultrasound to save the x-ray examination.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). Several pharmacologic and procedure-related measurements have been established for post-ERCP pancreatitis (PEP) prophylaxis one being the placement of pancreatic duct stents in patients with high risk for PEP. The beneficial role of pancreatic stenting in the prophylaxis of PEP was demonstrated in large meta-analyses. The used stents have a high potential of self dislodgment, retained stents have to be removed endoscopically after 5-10 days. For evaluation of spontaneous stent passage abdominal x-ray ist used and accordingly retained stents removed. The current study aimed to analyze whether prophylactic pancreatic stents can be detected by transdermal ultrasound to save the x-ray examination.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Frankfurt am Main, Germany
        • Klinikum der J.W. Goethe-Universitat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patient after pancreatic stent placement for prophylaxis of post-ERCP pancreatitis
  • age 18-79
  • signed informed consent

Exclusion Criteria:

  • any disease that rules out study participation
  • patient not legally competent to sign informed consent
  • chronic pancreatis as indication for pancreatic stenting

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with pancreatic stent
abdominal ultrasound and x-ray for stent detection.
Diagnostic test: Abdominal ultrasound
Abdominal ultrasound for detection of the pancreatic stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive predictive value of the sonographic detection of pancreatic stents
Time Frame: 5-10 days after stent placement
Test whether the stents can be detected reliably by ultrasound
5-10 days after stent placement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Negative predictive value of the sonographic detection of pancreatic stents
Time Frame: 5-10 days after stent placement
Test whether and why the stents cannot be detected reliably by ultrasound
5-10 days after stent placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Investigators

  • Principal Investigator: Mireen Friedrich-Rust, MD, Goethe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

April 21, 2020

Study Completion (Actual)

April 21, 2020

Study Registration Dates

First Submitted

August 25, 2018

First Submitted That Met QC Criteria

August 25, 2018

First Posted (Actual)

August 28, 2018

Study Record Updates

Last Update Posted (Actual)

April 22, 2020

Last Update Submitted That Met QC Criteria

April 21, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 419/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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