NCT04408482

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
268

participants targeted

Target at P75+ for not_applicable

Timeline
27mo left

Started Aug 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Aug 2020Sep 2028

First Submitted

Initial submission to the registry

May 26, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

March 3, 2026

Status Verified

March 1, 2025

Enrollment Period

8.1 years

First QC Date

May 26, 2020

Last Update Submit

February 27, 2026

Conditions

Endoscopic Retrograde Cholangiopancreatography

Outcome Measures

Primary Outcomes (1)

  • Post-ERCP pancreatitis rate

    30 days

Study Arms (2)

Pancreatic sphincterotomy

ACTIVE COMPARATOR

Pancreatic sphincterotomy performed in difficult cannulation

Device: Biliary cannulation

Pancreatic sphincterotomy + pancreatic stent

ACTIVE COMPARATOR

Pancreatic sphincterotomy performed in difficult cannulation + pancreatic stent placement

Device: Biliary cannulation

Interventions

Biliary cannulationDEVICE

Cannulation of biliary duct by sphincterotome

Pancreatic sphincterotomyPancreatic sphincterotomy + pancreatic stent

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki Univeristy Hospital

Helsinki, Finland

RECRUITING

Central Study Contacts

Andrea Tenca, MD, PhD

CONTACT

+358408484955ante14@hotmail.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 26, 2020

First Posted

May 29, 2020

Study Start

August 1, 2020

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

March 3, 2026

Record last verified: 2025-03

Locations

FI(1)