Sonographic Detection of Prophylactic Pancreatic Stents

Sponsor

Johann Wolfgang Goethe University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03649399

Collaborator

(none)

Enrollment

Location

Arm

25.7

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatitis Stent Dislodgement	Diagnostic Test: Abdominal ultrasound	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Mar 1, 2018

Actual Primary Completion Date :

Apr 21, 2020

Actual Study Completion Date :

Apr 21, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients with pancreatic stent abdominal ultrasound and x-ray for stent detection.	Diagnostic Test: Abdominal ultrasound Abdominal ultrasound for detection of the pancreatic stent

Arm

Intervention/Treatment

Experimental: Patients with pancreatic stent

abdominal ultrasound and x-ray for stent detection.

Diagnostic Test: Abdominal ultrasound

Abdominal ultrasound for detection of the pancreatic stent

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinikum der J.W. Goethe-Universität	Frankfurt am Main		Germany

Sponsors and Collaborators

Johann Wolfgang Goethe University Hospital

Investigators

Principal Investigator: Mireen Friedrich-Rust, MD, University Hospital Frankfurt

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Georg Dultz, Prof., Johann Wolfgang Goethe University Hospital

ClinicalTrials.gov Identifier:

NCT03649399

Other Study ID Numbers:

419/17

First Posted:

Aug 28, 2018

Last Update Posted:

Apr 22, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pancreatitis

Study Results

No Results Posted as of Apr 22, 2020