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

Learning Curve of Double-wire Cannulation Technique During Endoscopic Retrograde Cholangiopancreatography(ERCP): a Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Endoscopic Retrograde Cholangiopancreatography; Biliary Cannulation
• Intervention / Treatment: Procedure: DWT learning curve

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

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: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Procedure: DWT learning curve; trainees learn to perform DWT after unsuccessful initial cannulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful cannulation time with DWT by trainees	Successful cannulation time was defined by the time taken from the begining of DWT to entering bile duct successfully	3 hours
Cannulation attempts with DWT by trainees	One cannulation attempt was defined by touching papilla for more than 5 seconds.	3 hours
Precut rate	Precut includes the procedure of cannulation involving needle knife or dual knife and transpancreatic precut by a sphincterotome.	3 hours
post-ERCP pancreatitis(PEP)	PEP is defined according to Cotton's criteria. The severity classification is based on revised Atlanta criteria.	48 hours
Overall ERCP-related complications	Overall ERCP-related complations include PEP, bleeding, perforation, cholangitis and others, which is defined by Cotton's criteria.	48 hours

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2018
• Primary Completion (Actual): August 28, 2019
• Study Completion (Actual): September 29, 2019

Study Registration Dates

• First Submitted: October 12, 2018
• First Submitted That Met QC Criteria: October 12, 2018
• First Posted (Actual): October 16, 2018

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 23, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: ERCP; double guidewire technique; learning curve
• Other Study ID Numbers: KY20180081-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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