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

• ClinicalTrials.gov Identifier: NCT03707613
• Recruitment Status: Completed
• First Posted: October 16, 2018
• Last Update Posted: January 27, 2020
• Sponsor: Air Force Military Medical University, China
• Information provided by (Responsible Party): Yanglin Pan, Air Force Military Medical University, China

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Biliary Cannulation; Endoscopic Retrograde Cholangiopancreatography	Procedure: DWT learning curve	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Learning Curve of Double-wire Cannulation Technique During Endoscopic Retrograde Cholangiopancreatography(ERCP): a Pilot Study
• Actual Study Start Date: October 15, 2018
• Actual Primary Completion Date: August 28, 2019
• Actual Study Completion Date: September 29, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Successful cannulation of bile duct within 5min or 5 attempts of cannulation [ Time Frame: 3 hours ]
   It was defined by assurance of entering bile duct through cholangiogram during fluoroscopy.

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

China, Shaanxi

Endoscopic center, Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, China, 710032

Sponsors and Collaborators

Air Force Military Medical University, China

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Yanglin Pan, Associate Professor, Air Force Military Medical University, China
• ClinicalTrials.gov Identifier: NCT03707613
• Other Study ID Numbers: KY20180081-3
• First Posted: October 16, 2018
• Last Update Posted: January 27, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yanglin Pan, Air Force Military Medical University, China:

ERCP; double guidewire technique; learning curve