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

NCT ID: NCT04408482

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

268 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2024-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Endoscopic Retrograde Cholangiopancreatography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pancreatic sphincterotomy

Pancreatic sphincterotomy performed in difficult cannulation

Group Type ACTIVE_COMPARATOR

Biliary cannulation

Intervention Type DEVICE

Cannulation of biliary duct by sphincterotome

Pancreatic sphincterotomy + pancreatic stent

Pancreatic sphincterotomy performed in difficult cannulation + pancreatic stent placement

Group Type ACTIVE_COMPARATOR

Biliary cannulation

Intervention Type DEVICE

Cannulation of biliary duct by sphincterotome

Interventions

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Biliary cannulation

Cannulation of biliary duct by sphincterotome

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Consecutive patients with naïve papilla presenting to ERCP with indication of common bile duct (CBD) cannulation will be considered to the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Andrea Tenca

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Helsinki Univeristy Hospital

Helsinki, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Andrea Tenca, MD, PhD

Role: CONTACT

+358408484955

Facility Contacts

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Andrea Tenca, PhD

Role: primary

Other Identifiers

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3509/2019

Identifier Type: -

Identifier Source: org_study_id

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