Pancreatic Sphincterotomy Versus Double Wire Technique in Difficult Cannulation
1 other identifier
interventional
1,190
1 country
1
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 3, 2015
CompletedFirst Posted
Study publicly available on registry
September 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedMay 20, 2021
May 1, 2021
5.1 years
September 3, 2015
May 18, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Biliary cannulation success within 15 minutes after randomization
15 minutes
Biliary cannulation success, total number
2 hours
Study Arms (2)
Pancreatic sphincterotomy
ACTIVE COMPARATORPancreatic sphincterotomy technique used in difficult biliary cannulation
Double guide wire
ACTIVE COMPARATORDouble guide wire technique used in difficult biliary cannulation
Interventions
Eligibility Criteria
You may qualify if:
- Naive papilla, ERCP indication common bile duct cannulation
You may not qualify if:
- No consent to the study
- Ongoing pancreatitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Helsinki University Central Hospitallead
- Turku University Hospitalcollaborator
- Oulu University Hospitalcollaborator
Study Sites (1)
Helsinki University Hospital
Helsinki, Finland
Related Publications (1)
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.
PMID: 24628493BACKGROUND
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D, Ph.D
Study Record Dates
First Submitted
September 3, 2015
First Posted
September 14, 2015
Study Start
September 1, 2015
Primary Completion
September 30, 2020
Study Completion
December 30, 2020
Last Updated
May 20, 2021
Record last verified: 2021-05