Clinical trial NCT04546867: Establishing a Sonographic Based Algorithm to Verify Pancreatic Stent Position Placed to Prevent Post-ERCP Pancreatitis Before Endoscopic Removal
Official title: Sonographic Based Visualization Instead of X-ray of Pancreatic Stents Placed to Prenvent Post-ERCP Pancreatitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-ERCP Acute Pancreatitis
Pancreatic Stent
Ultrasound
X-rays
Keywords: Post-ERCP Acute Pancreatitis
Pancreatic Stent
Ultrasound
X-rays
Endoscopy
Esophagogastroduodenoscopy
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: The participants will start with a diagnostic ultrasound to visualize a pancreatic stent. If a stent is being displayed in the pancreatic duct. The participants will undergo endoscopy for removal of the pancreatic stent. Otherwise, x-ray will be performed to confirm the sonographic diagnosis. Stents, that are visulized in the duct by x-ray will than be removed. If sonography and x-ray confirm a spontanous dislodgement of the pancreatic stent, no further investigation will be performed.
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: The entire procedure will take place within one hour.
Secondary outcomes:
measure: 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.
timeFrame: Both will take place within 30 minutes.
measure: 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.
timeFrame: The entire procedure will take place within one hour.
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Klinikum der J. W. Goethe-Universität
Study officials:
References:
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