Pancreatic Sphincterotomy Versus Double Wire Technique in Difficult Cannulation

• Sponsor: Helsinki University Central Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02548884
• Collaborator: Turku University Hospital (Other), Oulu University Hospital (Other)
• Enrollment: 1,190
• Location: 1
• Arms: 2
• Duration (Months): 64
• Patients Per Site Per Month: 18.6

Study Details

Study Description

Brief Summary

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 .

Condition or Disease	Intervention/Treatment	Phase
Endoscopic Retrograde Cholangiopancreatography	Procedure: Biliary cannulation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 1190 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Sep 30, 2020
• Actual Study Completion Date: Dec 30, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Post ERCP pancreatitis defined by ESGE guidelines published 2014 [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 Outcome Measures

1. Biliary cannulation success within 15 minutes after randomization [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 [2 hours]

   The total number of successful biliary cannulations after randomization

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Naive papilla, ERCP indication common bile duct cannulation

Exclusion Criteria:

• No consent to the study

• Ongoing pancreatitis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Helsinki University Hospital	Helsinki		Finland

Sponsors and Collaborators

• Helsinki University Central Hospital
• Turku University Hospital
• Oulu University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Halttunen J, Meisner S, Aabakken L, Arnelo U, Grönroos J, Hauge T, Kleveland PM, Nordblad Schmidt P, Saarela A, Swahn F, Toth E, Mustonen H, Löhr 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.

• Responsible Party: Leena Kylanpaa, M.D, Ph.D, Helsinki University Central Hospital
• ClinicalTrials.gov Identifier: NCT02548884
• Other Study ID Numbers: Difficult cannulation
• First Posted: Sep 14, 2015
• Last Update Posted: May 20, 2021
• Last Verified: May 1, 2021

Study Results

No Results Posted as of May 20, 2021