Back to resultsDoes Pancreatic Stent Decrease the Risk of Pancreatitis After Pancreatic Sphincterotomy for Difficult Cannulation?
Primary Purpose
Endoscopic Retrograde Cholangiopancreatography
Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Biliary cannulation
Sponsored by
About this trial
This is an interventional treatment trial for Endoscopic Retrograde Cholangiopancreatography
Eligibility Criteria
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.
Sites / Locations
- Helsinki Univeristy HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Pancreatic sphincterotomy
Pancreatic sphincterotomy + pancreatic stent
Arm Description
Pancreatic sphincterotomy performed in difficult cannulation
Pancreatic sphincterotomy performed in difficult cannulation + pancreatic stent placement
Outcomes
Primary Outcome Measures
Post-ERCP pancreatitis rate
Secondary Outcome Measures
Full Information
NCT ID
NCT04408482
First Posted
May 26, 2020
Last Updated
March 24, 2022
Sponsor
Helsinki University Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04408482
Brief Title
Does Pancreatic Stent Decrease the Risk of Pancreatitis After Pancreatic Sphincterotomy for Difficult Cannulation?
Official Title
Does Pancreatic Stent Decrease the Risk of Pancreatitis After Pancreatic Sphincterotomy for Difficult Cannulation?
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endoscopic Retrograde Cholangiopancreatography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
268 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pancreatic sphincterotomy
Arm Type
Active Comparator
Arm Description
Pancreatic sphincterotomy performed in difficult cannulation
Arm Title
Pancreatic sphincterotomy + pancreatic stent
Arm Type
Active Comparator
Arm Description
Pancreatic sphincterotomy performed in difficult cannulation + pancreatic stent placement
Intervention Type
Device
Intervention Name(s)
Biliary cannulation
Intervention Description
Cannulation of biliary duct by sphincterotome
Primary Outcome Measure Information:
Title
Post-ERCP pancreatitis rate
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Tenca, MD, PhD
Phone
+358408484955
Email
ante14@hotmail.it
Facility Information:
Facility Name
Helsinki Univeristy Hospital
City
Helsinki
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Tenca, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Does Pancreatic Stent Decrease the Risk of Pancreatitis After Pancreatic Sphincterotomy for Difficult Cannulation?
We'll reach out to this number within 24 hrs