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Clinical Trials/NCT04609917
NCT04609917
Completed
Not Applicable

Proposal of Difficult Cannulation Criteria in Trainee Involved ERCP Cannulation Procedure

Air Force Military Medical University, China1 site in 1 country4,415 target enrollmentMarch 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Biliary Cannulation
Sponsor
Air Force Military Medical University, China
Enrollment
4415
Locations
1
Primary Endpoint
rates of difficult cannulation
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2020
End Date
October 20, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Air Force Military Medical University, China
Responsible Party
Principal Investigator
Principal Investigator

Yanglin Pan

Associate Professor

Air Force Military Medical University, China

Eligibility Criteria

Inclusion Criteria

  • patients with native papilla

Exclusion Criteria

  • indications of major or minor pancreatic duct (PD) cannulation; no attempts of cannulation due to inaccessible papilla; cannulation via the papillary fistula; patients with duodenal stenosis or anatomical deformity secondary to prior surgery.

Outcomes

Primary Outcomes

rates of difficult cannulation

Time Frame: 2 hours

The proportion of the participants with cannulation-related parameters (cannulation time, cannulation attempts, or inadvertent PD cannulation) above the 75% percentile

Secondary Outcomes

  • the proportion of advanced cannulation methods(4 hours)
  • incidences of PEP(48 hours)
  • overall adverse events(48 hours)

Study Sites (1)

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