Does Pancreatic Stent Decrease the Risk of Pancreatitis After Pancreatic Sphincterotomy for Difficult Cannulation?
Sponsor
Helsinki University Central Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04408482
Collaborator
(none)
268
1
2
49
5.5
Study Details
Study Description
Brief Summary
The purpose of the study is to compare the risk of PEP after pancreatic sphincterotomy performed for difficult cannulation in a group of patients with and in a group of patients without placement of a prophylactic pancreatic stent. The definition of difficult cannulation is defined according to the literature.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
268 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Does Pancreatic Stent Decrease the Risk of Pancreatitis After Pancreatic Sphincterotomy for Difficult Cannulation?
Actual Study Start Date
:
Aug 1, 2020
Anticipated Primary Completion Date
:
Sep 1, 2024
Anticipated Study Completion Date
:
Sep 1, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Pancreatic sphincterotomy Pancreatic sphincterotomy performed in difficult cannulation |
Device: Biliary cannulation
Cannulation of biliary duct by sphincterotome
|
| Active Comparator: Pancreatic sphincterotomy + pancreatic stent Pancreatic sphincterotomy performed in difficult cannulation + pancreatic stent placement |
Device: Biliary cannulation
Cannulation of biliary duct by sphincterotome
|
Outcome Measures
Primary Outcome Measures
- Post-ERCP pancreatitis rate [30 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Consecutive patients with naïve papilla presenting to ERCP with indication of common bile duct (CBD) cannulation will be considered to the study.
Exclusion Criteria:
- Exclusion criteria are age below 18 years, acute pancreatitis and no consent to the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Helsinki Univeristy Hospital | Helsinki | Finland |
Sponsors and Collaborators
- Helsinki University Central Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Andrea Tenca,
Principal investigator,
Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT04408482
Other Study ID Numbers:
- 3509/2019
First Posted:
May 29, 2020
Last Update Posted:
Mar 25, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms: