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

NCT03707613 | Completed DMC

• 1 other identifier: KY20180081-3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

ERCP; double guidewire technique; learning curve

Outcome Measures

Primary Outcomes (1)

• Successful cannulation of bile duct within 5min or 5 attempts of cannulation

  It was defined by assurance of entering bile duct through cholangiogram during fluoroscopy.

  3 hours

Secondary Outcomes (5)

• Successful cannulation time with DWT by trainees

  3 hours

• Cannulation attempts with DWT by trainees

  3 hours

• Precut rate

  3 hours

• post-ERCP pancreatitis(PEP)

  48 hours

• Overall ERCP-related complications

  48 hours

Study Arms (1)

DWT learning curve

EXPERIMENTAL

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.

Procedure: DWT learning curve

Interventions

DWT learning curve PROCEDURE

trainees learn to perform DWT after unsuccessful initial cannulation

DWT learning curve

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Endoscopic center, Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

• 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.

  PMID: 32473040 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 12, 2018
• First Posted: October 16, 2018
• Study Start: October 15, 2018
• Primary Completion: August 28, 2019
• Study Completion: September 29, 2019
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)