Does Pancreatic Stent Decrease the Risk of Pancreatitis A... | NCT04408482

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

NCT04408482

Sponsor

Helsinki University Central Hospital

Status

Recruiting

Last Update Posted

Mar 3, 2026Actual

Enrollment

268Estimated

Phase

Not Applicable

Conditions

Endoscopic Retrograde Cholangiopancreatography

Interventions

Biliary cannulation

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2020Actual

Primary Completion Date

Sep 1, 2028Estimated

Completion Date

Sep 1, 2028Estimated

First Submitted Date

May 26, 2020

First Submission Date that Met QC Criteria

May 26, 2020

First Posted Date

May 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2026

Last Update Posted Date

Mar 3, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andrea Tenca, Principal investigator, Helsinki University Central HospitalPrincipal Investigator

Lead Sponsor

Helsinki University Central HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

268Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Biliary cannulation	Device	Cannulation of biliary duct by sphincterotome	Pancreatic sphincterotomy Pancreatic sphincterotomy + pancreatic stent

Measure	Description	Time Frame
Post-ERCP pancreatitis rate		30 days

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andrea Tenca, MD, PhD	Contact	+358408484955		ante14@hotmail.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helsinki Univeristy Hospital	Recruiting	Helsinki			Finland

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided