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 .

Study Overview

• Status: Completed
• Conditions: Endoscopic Retrograde Cholangiopancreatography
• Intervention / Treatment: Procedure: Biliary cannulation

• Study Type: Interventional
• Enrollment (Actual): 1190
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland
    • Helsinki University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Naive papilla, ERCP indication common bile duct cannulation

Exclusion Criteria:

• No consent to the study
• Ongoing pancreatitis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pancreatic sphincterotomy; Pancreatic sphincterotomy technique used in difficult biliary cannulation	Procedure: Biliary cannulation
Active Comparator: Double guide wire; Double guide wire technique used in difficult biliary cannulation	Procedure: Biliary cannulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post ERCP pancreatitis defined by ESGE guidelines published 2014	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.	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biliary cannulation success within 15 minutes after randomization	After randomization, timing to get the wire in biliary duct. First assessed the number of procedures succeeded in 15 minutes.	15 minutes
Biliary cannulation success, total number	The total number of successful biliary cannulations after randomization	2 hours

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Collaborators: Turku University Hospital; Oulu University Hospital

Publications and helpful links

General Publications

• Halttunen J, Meisner S, Aabakken L, Arnelo U, Gronroos J, Hauge T, Kleveland PM, Nordblad Schmidt P, Saarela A, Swahn F, Toth E, Mustonen H, Lohr JM. Difficult cannulation as defined by a prospective study of the Scandinavian Association for Digestive Endoscopy (SADE) in 907 ERCPs. Scand J Gastroenterol. 2014 Jun;49(6):752-8. doi: 10.3109/00365521.2014.894120. Epub 2014 Mar 14.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: September 3, 2015
• First Submitted That Met QC Criteria: September 11, 2015
• First Posted (Estimate): September 14, 2015

Study Record Updates

• Last Update Posted (Actual): May 20, 2021
• Last Update Submitted That Met QC Criteria: May 18, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Difficult cannulation