Sonographic Detection of Prophylactic Pancreatic Stents

Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03649399
• Other study ID #: 419/17
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: April 21, 2020

Study information

• Verified date: April 2020
• Source: Johann Wolfgang Goethe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 21, 2020
• Est. primary completion date: April 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatitis
• Stent Dislodgement

Intervention

Diagnostic Test:
• Abdominal ultrasound
Abdominal ultrasound for detection of the pancreatic stent

Locations

Country	Name	City	State
Germany	Klinikum der J.W. Goethe-Universität	Frankfurt am Main

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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