Endoscopic center, Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, 710032, China
NCT Number: NCT04609917
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.
Looking for future studies?
Notify MeAll sexes
Observational
Xi'an, Shaanxi, 710032, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients underwent selective biliary cannulation with trainee involvement
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
Time frame: 48 hours
Time frame: 48 hours
Time frame: 4 hours
Air Force Military Medical University, China
Other
Proposal of Difficult Cannulation Criteria in Trainee Involved ERCP Cannulation Procedure
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03707613
Biliary Cannulation, Endoscopic Retrograde Cholangiopancreatography
Xi'an, Shaanxi, China
View Trial DetailsNCT03582540
Biliary Cannulation, Catheterization
Charenton-le-Pont, France
View Trial DetailsNCT05122858
Biliary Drainage, Echography Ultrasound
Paris, France
View Trial DetailsNCT07328477
Agnosia, Anxiety
Istanbul, Turkey (Türkiye)
View Trial Details