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

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.

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Key information

Conditions

Endoscopic Retrograde Cholangiopancreatography

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki Univeristy Hospital

Helsinki, Finland

Location status: Recruiting

Location contact

Andrea Tenca, PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biliary cannulation

Device

Cannulation of biliary duct by sphincterotome

Primary outcomes

Post-ERCP pancreatitis rate

Time frame: 30 days

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Tenca, MD, PhD

CONTACT

[email protected]

+358408484955

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2028
Study completion: 2028
First posted: May 29, 2020
Registry last updated: Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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