Sonographic Detection of Prophylactic Pancreatic Stents

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pancreatitis, Stent Dislodgement

Intervention / Treatment
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* Diagnostic Test: Abdominal ultrasound


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with pancreatic stent<br>abdominal ultrasound and x-ray for stent detection. | Diagnostic Test: Abdominal ultrasound<br>* Abdominal ultrasound for detection of the pancreatic stent<br>|

What is the study measuring?
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Primary Outcome Measures

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