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Establishing a Sonographic Based Algorithm to Verify Pancreatic Stent Position Placed to Prevent Post-ERCP Pancreatitis Before Endoscopic Removal

NCT04546867 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2023-07-13

No results posted yet for this study

Summary

The present study is a prospective, single-center study. A total of 88 patients, who had placed a pancreatic stent for preventing post-ERCP pancreatitis, will be included in the study. Aim of the study is to establish a new algorithm based on a sonographic approach to remove the placed pancreatic stents. Another aim is to compare high-end sonographic devices with devices of medium price scale one's used on the ward.

On the day of removal of the pancreatic stent, all patients receive a sonography by an experienced investigator on the ward and by another, uninformed investigator with a high-end device. If a pancreatic stent is visualized in the pancreatic duct, the patient will have an esophagogastroduodenoscopy to remove the pancreatic stent. If sonography cannot find a pancreatic stent in the pancreatic duct an x-ray will be performed as suggested by the European and international guidelines. If the pancreatic stent spontaneously dislocated into the small bowel tract according to x-ray, no further investigation will be performed. If a stent is visulized in situ by x-ray, it will be removed by endoscopyl.

Statistical analysis will be done in cooperation with the statistical biomedical institute oft he university hospital in Frankfurt.

Conditions

  • Post-ERCP Acute Pancreatitis
  • Pancreatic Stent
  • Ultrasound
  • X-rays

Interventions

DIAGNOSTIC_TEST

Sonographic based visualization of a pancreatic stent

As described above. All patients start with an ultasound-based approach to visualize pancreatic stents position. Depending on the findings, x-ray will be performed if no stent is visualized in the pancreatic duct or an esophagogastroduodenoscopy will be performed to remove the pancreatic stent and confirm sonographic findings if the pancreatic stent is displayed in situ.

Sponsors & Collaborators

  • Johann Wolfgang Goethe University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-07
Primary Completion
2023-04-21
Completion
2023-04-21

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04546867 on ClinicalTrials.gov