Back to resultsSonographic Detection of Prophylactic Pancreatic Stents
Primary Purpose
Pancreatitis, Stent Dislodgement
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Abdominal ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Pancreatitis
Eligibility Criteria
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
Sites / Locations
- Klinikum der J.W. Goethe-Universität
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with pancreatic stent
Arm Description
abdominal ultrasound and x-ray for stent detection.
Outcomes
Primary Outcome Measures
Positive predictive value of the sonographic detection of pancreatic stents
Test whether the stents can be detected reliably by ultrasound
Secondary Outcome Measures
Negative predictive value of the sonographic detection of pancreatic stents
Test whether and why the stents cannot be detected reliably by ultrasound
Full Information
NCT ID
NCT03649399
First Posted
August 25, 2018
Last Updated
April 21, 2020
Sponsor
Johann Wolfgang Goethe University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03649399
Brief Title
Sonographic Detection of Prophylactic Pancreatic Stents
Official Title
Sonographic Detection of Pancreatic Stents Placed for Prophylaxis of Post-ERCP Pancreatitis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
April 21, 2020 (Actual)
Study Completion Date
April 21, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johann Wolfgang Goethe University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis, Stent Dislodgement
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with pancreatic stent
Arm Type
Experimental
Arm Description
abdominal ultrasound and x-ray for stent detection.
Intervention Type
Diagnostic Test
Intervention Name(s)
Abdominal ultrasound
Intervention Description
Abdominal ultrasound for detection of the pancreatic stent
Primary Outcome Measure Information:
Title
Positive predictive value of the sonographic detection of pancreatic stents
Description
Test whether the stents can be detected reliably by ultrasound
Time Frame
5-10 days after stent placement
Secondary Outcome Measure Information:
Title
Negative predictive value of the sonographic detection of pancreatic stents
Description
Test whether and why the stents cannot be detected reliably by ultrasound
Time Frame
5-10 days after stent placement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mireen Friedrich-Rust, MD
Organizational Affiliation
Goethe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum der J.W. Goethe-Universität
City
Frankfurt am Main
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33887119
Citation
Michael FA, Gerber L, Weiler N, Hunyady PM, Abedin N, de la Vera AL, Stoffers P, Filmann N, Zeuzem S, Bojunga J, Friedrich-Rust M, Dultz G. Transabdominal ultrasonography to reduce the burden of X-ray imaging in prophylactic pancreatic stent localization after ERCP-A prospective trial. United European Gastroenterol J. 2021 May;9(4):469-477. doi: 10.1002/ueg2.12063. Epub 2021 Apr 22.
Results Reference
derived
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Sonographic Detection of Prophylactic Pancreatic Stents
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