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Proposal of Difficult Cannulation Criteria in Trainee Involved ERCP Cannulation Procedure
Endoscopic Retrograde Cholangiopancreatography (ERCP) is one of the most technically challenging procedures in gastrointestinal endoscopy. Selective deep cannulation is a critical step for the performance of ERCP. The incidence of difficult cannulation has been reported in many studies, ranging from 10% to 40% in patients with native papilla. Difficult cannulation is an independent risk factor for post-ERCP pancreatitis (PEP). The definition of difficult cannulation has been proposed by European Society of Gastrointestinal Endoscopy (ESGE) guidelines. Initial cannulation is considered difficult with the presence of one or more of the following: more than 5 min for attempting to cannulate; more than 5 contacts with the papilla; more than 1 unintended pancreatic duct cannulation or opacification. The clear definition of difficult cannulation is important for making decisions during or after ERCP, including determining the appropriate time to transfer to advanced cannulation techniques (e.g. early precut) and whether prophylactic methods should be administrated to reduce the risk of PEP. Although 5-5-1 criteria have been widely used during ERCP practice or in relevant studies, it remains unclear whether the current criteria are suitable for the cannulation procedure with trainee involvement. Because of inexperienced manipulation of the scope and accessories, the involvement of trainees generally increases the overall cannulation time and attempts, which are the two important parameters in the criteria of difficult cannulation. Thus, the investigators hypothesized that the definition of difficult cannulation in trainee-involved cannulation might be different from the traditional 5-5-1 criteria.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Endoscopic center, Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, China
Start Date
March 1, 2020
Primary Completion Date
October 1, 2020
Completion Date
October 20, 2020
Last Updated
October 30, 2020
4,415
ACTUAL participants
trainee invlovement
PROCEDURE
Lead Sponsor
Air Force Military Medical University, China
NCT04408482
NCT07440342
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07017283