Menu
Recruiting NCT04408482

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

No phase Interventional Endoscopic Retrograde Cholangiopancreatography

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biliary cannulation.
Who it may be relevant to
Registry conditions: Endoscopic Retrograde Cholangiopancreatography. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Biliary cannulation
    Cannulation of biliary duct by sphincterotome

Primary outcome measures

  • Post-ERCP pancreatitis rate [Time frame: 30 days]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Finland · 1 center
  • Helsinki Univeristy Hospital — Helsinki

Identifiers

NCT: NCT04408482 · 3509/2019

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗