Difficult Cannulation Criteria in Trainee Involved ERCP Cannulation

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.

Study Overview

• Status: Completed
• Conditions: Endoscopic Retrograde Cholangiopancreatography; Biliary Cannulation
• Intervention / Treatment: Procedure: trainee invlovement

• Study Type: Observational
• Enrollment (Actual): 4415

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Endoscopic center, Xijing Hospital of Digestive Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with native papilla who underwent ERCP in Xijing Hospital in China

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
trainee group; Patients with native papilla who underwent selective biliary cannulation with trainee involvement	Procedure: trainee invlovement; Patients underwent selective biliary cannulation with trainee involvement
non-trainee group; Patients with native papilla who underwent selective biliary cannulation without trainee involvement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rates of difficult cannulation	The proportion of the participants with cannulation-related parameters (cannulation time, cannulation attempts, or inadvertent PD cannulation) above the 75% percentile	2 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
incidences of PEP	48 hours
overall adverse events	48 hours
the proportion of advanced cannulation methods	4 hours

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China

Publications and helpful links

General Publications

• Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.
• Ismail S, Udd M, Lindstrom O, Rainio M, Halttunen J, Kylanpaa L. Criteria for difficult biliary cannulation: start to count. Eur J Gastroenterol Hepatol. 2019 Oct;31(10):1200-1205. doi: 10.1097/MEG.0000000000001515.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): October 20, 2020

Study Registration Dates

• First Submitted: October 23, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (Actual): October 30, 2020

Study Record Updates

• Last Update Posted (Actual): October 30, 2020
• Last Update Submitted That Met QC Criteria: October 29, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: ERCP; PEP; Difficult cannulation; Trainee
• Other Study ID Numbers: KY20201021-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No