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OpenTrials
Completed

NCT Number: NCT02548884

Pancreatic Sphincterotomy Versus Double Wire Technique in Difficult Cannulation

The purpose of the study is to compare two different techniques (pancreatic sphincterotomy (PS) and double wire technique (DGW)) regarding the risk of post-ERCP pancreatitis (PEP) and the success of cannulation in difficult cannulation. For the study, the difficult cannulation is de-fined as situation when the common bile duct has not been cannulated in five minutes, after five attempts or after two pancreatic guide wire passages or when any of those limits is exceeded. The two techniques, the PS and the DGW, will be compared in random fashion. The primary end-point is the risk of PEP .

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Key information

Conditions

Endoscopic Retrograde Cholangiopancreatography

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Hospital

Helsinki, Finland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Naive papilla, ERCP indication common bile duct cannulation

Exclusion criteria

  • No consent to the study
  • Ongoing pancreatitis

Treatment and study plan

Biliary cannulation

Procedure

Primary outcomes

  1. Post ERCP pancreatitis defined by ESGE guidelines published 2014

    Time frame: 48 hours

    Acute pancreatitis within 48 hours post ERCP. Post-ERCP pancreatitis (PEP) is defined as the presence of abdominal pain attributable to acute pancreatitis, together with a need for an unplanned hospitalization or an extension of a planned hospitalization by at least 2 days, and a serum /plasma amylase at least 3 times above the upper limit of normal at 24 hours after the procedure.

Secondary outcomes

  1. Biliary cannulation success within 15 minutes after randomization

    Time frame: 15 minutes

    After randomization, timing to get the wire in biliary duct. First assessed the number of procedures succeeded in 15 minutes.

  2. Biliary cannulation success, total number

    Time frame: 2 hours

    The total number of successful biliary cannulations after randomization

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • Oulu University Hospital
  • Turku University Hospital

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Sep 14, 2015
Registry last updated
May 20, 2021

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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