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NCT02548884 Clinical Trial

Pancreatic Sphincterotomy Versus Double Wire Technique in Difficult Cannulation

Endoscopic Retrograde Cholangiopancreatography Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02548884
Other study ID # Difficult cannulation
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2015
Est. completion date December 30, 2020

Study information
Verified date May 2021
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 .

Recruitment information / eligibility
Status Completed
Enrollment 1190
Est. completion date December 30, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Naive papilla, ERCP indication common bile duct cannulation Exclusion Criteria: - No consent to the study - Ongoing pancreatitis

Study Design

Related Conditions & MeSH terms

  • Endoscopic Retrograde Cholangiopancreatography

Intervention

Procedure:
• Biliary cannulation

Locations
Country Name City State
Finland Helsinki University Hospital Helsinki

Sponsors (3)
Lead Sponsor Collaborator
Helsinki University Central Hospital Oulu University Hospital, Turku University Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Biliary cannulation success, total number The total number of successful biliary cannulations after randomization 2 hours
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