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

Study Overview
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Brief Summary
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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.

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

Conditions
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Post-ERCP Acute Pancreatitis, Pancreatic Stent, Ultrasound, X-rays

Intervention / Treatment
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* Diagnostic Test: Sonographic based visualization of a pancreatic stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Sequential Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sonography arm<br>Sonography is being performed by expericenced investigators to visualize a pancreatic stent in the pancreatic duct. If the stent is being visualized, an endoscopy will be performed to remove the stent. Otherwise, x-ray will be needed to confirm the sonographic finding of a dislodged pancreatic stent with no further need of intervention. If x-ray finds a pancreatic stent in situ opposingly to ultrasound, an endoscopy will be performed to confirm the stents position and eventually remove it. | Diagnostic Test: Sonographic based visualization of a pancreatic stent<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | The entire procedure will take place within one hour. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Both will take place within 30 minutes. | 
| 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. | Baseline characteristics will be compared to the false-positive and false-negative results of sonography compared to the gold standard (x-ray/endoscopy) | The entire procedure will take place within one hour. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopy, Esophagogastroduodenoscopy, Post-ERCP Acute Pancreatitis, Pancreatic Stent, Ultrasound, X-rays