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NCT04408482 Clinical Trial

Does Pancreatic Stent Decrease the Risk of Pancreatitis After Pancreatic Sphincterotomy for Difficult Cannulation?

Endoscopic Retrograde Cholangiopancreatography Clinical Trial

Official title:
Does Pancreatic Stent Decrease the Risk of Pancreatitis After Pancreatic Sphincterotomy for Difficult Cannulation?

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04408482
Other study ID # 3509/2019
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2020
Est. completion date September 1, 2024

Study information
Verified date February 2024
Source Helsinki University Central Hospital
Contact Andrea Tenca, MD, PhD
Phone +358408484955
Email ante14@hotmail.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 268
Est. completion date September 1, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

  • Endoscopic Retrograde Cholangiopancreatography
  • Pancreatitis

Intervention

Device:
• Biliary cannulation
Cannulation of biliary duct by sphincterotome

Locations
Country Name City State
Finland Helsinki Univeristy Hospital Helsinki

Sponsors (1)
Lead Sponsor Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Post-ERCP pancreatitis rate 30 days
See also
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Completed NCT01505218 - Propofol Patient-controlled Sedation for Endoscopic Retrograde Cholangiopancreatography N/A
Completed NCT00867204 - Short Versus Long Wire ERCP Systems N/A
Completed NCT03707613 - Learning Curve of Double-wire Cannulation Technique During Endoscopic Retrograde Cholangiopancreatography (ERCP) N/A
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Completed NCT05122858 - EUS-guided Biliary Drainage of First Intent With the Lumen Apposing Metal Stent vs. ERCP in the Management of Malignant Distal Biliary Obstruction (AXIOS-CPRE) N/A
Completed NCT03550768 - Effect of Anatomy of Major Duodenal Papilla on the Difficulty of Cannulation During Endoscopic Retrograde Cholangiopancreatography
Recruiting NCT04903444 - Development and Validation of an Artificial Intelligence-based Biliary Stricture Navigation System in MRCP-based ERCP N/A
Completed NCT04103749 - Global Prospective Case Series Using a Single-Use Duodenoscope N/A
Completed NCT04609917 - Difficult Cannulation Criteria in Trainee Involved ERCP Cannulation
Recruiting NCT05947461 - Prevention of Post-ERCP Pancreatitis by Indomethacin vs Diclofenac N/A
Completed NCT04143698 - Reusable Versus Disposable Duodenoscopes for ERCP N/A
Completed NCT02992652 - Allopurinol in Prevention of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis N/A
Completed NCT01079312 - Patient-controlled Sedation With Propofol and Remifentanyl for Endoscopic Retrograde Cholangiopancreatography (ERCP) Phase 4
Completed NCT04223830 - Initial Case Series With Exalt Single-Use Duodenoscope - Expanded User Experience N/A
Recruiting NCT06277414 - a Prediction of Post-Endoscopic Retrograde Cholangiopancreatography Complication
Completed NCT06388525 - Post-ERCP Cholecystectomy. How ERCP and ERCP-related Variables Effect the Outcomes?
Recruiting NCT03413111 - Modified Double Wire Technique to Facilitate the Successful Cannulation N/A
Terminated NCT03057769 - Effect of Papillary Epinephrine Spraying on Post-ERCP Pancreatitis in Patients Received Rectal Indomethacin N/A