Learning Curve of Double-wire Cannulation Technique During Endoscopic Retrograde Cholangiopancreatography (ERCP)

NCT ID: NCT03707613

Last Updated: 2020-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-15
• Study Completion Date: 2019-09-29

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.

Conditions

Biliary Cannulation; Endoscopic Retrograde Cholangiopancreatography

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

DWT learning curve

Initial cannulation is performed with a wire-guided sphincterotome by a trainee. If the cannulation proves difficult (cannulation time \>10min, cannulation attemtps \>5 or inadvertent PD cannulation \>1) and PD is inadvertently entered, DWT will be performed by one of the two trainees. If DWT fails within 5min or 5 attempts, a trainer will take over and continue the cannulation. To prevent PEP, all patients receive prophylactic PD stent and post-ERCP rectal indomethacin. Aggressive hydartion will be administrated at the discretion of endoscopists.

Group Type: EXPERIMENTAL

DWT learning curve

Intervention Type: PROCEDURE

trainees learn to perform DWT after unsuccessful initial cannulation

Interventions

DWT learning curve

trainees learn to perform DWT after unsuccessful initial cannulation

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Air Force Military Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Yanglin Pan

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Endoscopic center, Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 32473040 (View on PubMed)

Other Identifiers

KY20180081-3

Identifier Type: -

Identifier Source: org_study_id