Clinical trial NCT03707613: Learning Curve of Double-wire Cannulation Technique During Endoscopic Retrograde Cholangiopancreatography (ERCP)
Official title: Learning Curve of Double-wire Cannulation Technique During Endoscopic Retrograde Cholangiopancreatography(ERCP): a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biliary Cannulation
Endoscopic Retrograde Cholangiopancreatography
Keywords: ERCP
double guidewire technique
learning curve
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2018-10-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Selective cannulation is considered the most challenging step for most of endoscopic retrograde cholangiopancreatography (ERCP). Wire-guided cannulation is the standard technique for initial cannulation. When meeting difficulty, double wire technique (DWT) is widely used. With one guidewire occupying pancreatic duct(PD) , the following cannulation of CBD with a sphincterome preloaded with another guidewire often becomes feasible.

When performing DWT, a sphincterotome should enter the common duct of papilla through a small orifice and be placed in the left and upper direction of PD guidewire. Then another guidewire can be advanced into bile duct. As an advanced cannulation technique, DWT can be successfully performed in up to 80% of difficult patients. However, it can be technically difficult, especially for trainees or endoscopists without adequate experience.

Here we planned to prospectively record the procedures of double-wire cannulation by two trainees without prior experience of DWT. This study aims to delinate the learning curve of DWT and its safety by trainees.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18-90 with native papilla
* patients with diffcult cannulation of bile duct
* Inadvertent pancreatic duct cannulation

Exclusion Criteria:

* Contraindications of ERCP
* Major or minor pancreatic duct as the targeted duct
* Prior EST or needle-knife precut before DWT
* Surgically altered gastrointestinal anatomy
* Papillary carcinoma or stone impaction within papilla
* Complete pancreas divisum
* Pregnant or breastfeeding women
* Unwilling or inability to provide consent

Primary outcomes:
measure: Successful cannulation of bile duct within 5min or 5 attempts of cannulation
timeFrame: 3 hours
Secondary outcomes:
measure: Successful cannulation time with DWT by trainees
timeFrame: 3 hours
measure: Cannulation attempts with DWT by trainees
timeFrame: 3 hours
measure: Precut rate
timeFrame: 3 hours
measure: post-ERCP pancreatitis(PEP)
timeFrame: 48 hours
measure: Overall ERCP-related complications
timeFrame: 48 hours
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Endoscopic center, Xijing Hospital of Digestive Diseases
state: Shaanxi
Study officials:
References:
citation: Wang X, Ren G, Xi Y, Luo H, Liang S, Wang B, Tao Q, Luo B, Qin Q, Farrell JJ, Guo X, Wu K, Pan Y. Learning curve of double-guidewire technique by trainees during hands-on endoscopic retrograde cholangiopancreatography training. J Gastroenterol Hepatol. 2020 Dec;35(12):2176-2183. doi: 10.1111/jgh.15120. Epub 2020 Jun 23.