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Completed

NCT Number: NCT04546867

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

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.

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Key information

Conditions

Post-ERCP Acute Pancreatitis Pancreatic Stent Ultrasound X-rays

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum der J. W. Goethe-Universität

Frankfurt am Main, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • placement of prophylactic pancreatic stent to prevent post-ERCP-pancreatitis
  • age of at least 18 years
  • written informed consent

Exclusion criteria

  • diseases that prevent sonography, x-ray or esophagogastroduodenoscopy
  • no given consent
  • other indication for pancreatic stenting

Treatment and study plan

Sonographic based visualization of a pancreatic stent

Diagnostic Test

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.

Primary outcomes

  1. Confirmation of a new algorithm to remove a prophylactic pancreatic stent placed to prevent post-ERCP pancreatitis by using sonography as first approach and compare the findings statistically in a pivot table to x-ray and endoscopy.

    Time frame: The entire procedure will take place within one hour.

    A new algorithm is supposed to be tested that starts with a sonography to display a pancreatic stent. If the pancreatic stent can be visualized in the pancreatic duct, an esophagogastroduodenoscopy will be performed directly to remove the stent. If the stent cannot be displayed by sonography, x-ray will be performed as commonly suggested by the European and international guidelines.

    Therefore, the main goal of the study is to implement sonography before further diagnostic modalities to confirm prophylactic pancreatic stents position in the pancreatic duct.

Secondary outcomes

  1. Comparison of the findings of high-end sonographic devices and the findings of medium prize sonographic devices used on the ward by using a pivot table.

    Time frame: Both will take place within 30 minutes.

    There will be performed two different ultrasounds to confirm stents position by two different experienced investigators. The results will be compared to the results of x-ray and/or endoscopy to evaluate the quality of high end to medium prize sonographic devices.

  2. Univariate analysis of the baseline characteristics compared to the results of sonographic findings to evaluate risk factors of false sonographic findings by using a Case report form to collect the data.

    Time frame: The entire procedure will take place within one hour.

    Baseline characteristics will be compared to the false-positive and false-negative results of sonography compared to the gold standard (x-ray/endoscopy)

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Official study title

Sonographic Based Visualization Instead of X-ray of Pancreatic Stents Placed to Prenvent Post-ERCP Pancreatitis.

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 14, 2020
Registry last updated
Jul 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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