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

Endoscopic Retrograde Cholangiopancreatography Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03707613
• Other study ID #: KY20180081-3
• Status: Completed
• Phase: N/A
• Start date: October 15, 2018
• Est. completion date: September 29, 2019

Study information

• Verified date: January 2020
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 29, 2019
• Est. primary completion date: August 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Biliary Cannulation
• Endoscopic Retrograde Cholangiopancreatography

Intervention

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

Locations

Country	Name	City	State
China	Endoscopic center, Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

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