Sonographic Detection of Prophylactic Pancreatic Stents

Not Applicable

Completed

• Conditions: Pancreatitis; Stent Dislodgement
• Interventions: Diagnostic Test: Abdominal ultrasound

• Registration Number: NCT03649399
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2018-08-25
• Study First Submitted QC: 2018-08-25
• Study First Posted: 2018-08-28
• Status Verified: 2020-04
• Primary Completion: 2020-04-21
• Study Completion: 2020-04-21
• Last Update Submitted: 2020-04-21
• Last Update Posted: 2020-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with pancreatic stent	Abdominal ultrasound	abdominal ultrasound and x-ray for stent detection.

Primary Outcome Measures

Name	Time	Method
Positive predictive value of the sonographic detection of pancreatic stents	5-10 days after stent placement	Test whether the stents can be detected reliably by ultrasound

Secondary Outcome Measures

Name	Time	Method
Negative predictive value of the sonographic detection of pancreatic stents	5-10 days after stent placement	Test whether and why the stents cannot be detected reliably by ultrasound

Trial Locations

Locations (1)

Klinikum der J.W. Goethe-Universität; 🇩🇪 Frankfurt am Main, Germany