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

Sponsor
Air Force Military Medical University, China (Other)
Overall Status
Completed
CT.gov ID
NCT03707613
Collaborator
(none)
60
Enrollment
1
Location
1
Arm
11.5
Actual Duration (Months)
5.2
Patients Per Site Per Month

Study Details

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
  • Procedure: DWT learning curve
 N/A

Study Design

Study Type:
Interventional
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 :
Oct 15, 2018
Actual Primary Completion Date :
Aug 28, 2019
Actual Study Completion Date :
Sep 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 [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 [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 [3 hours]

    One cannulation attempt was defined by touching papilla for more than 5 seconds.

  3. Precut rate [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) [48 hours]

    PEP is defined according to Cotton's criteria. The severity classification is based on revised Atlanta criteria.

  5. Overall ERCP-related complications [48 hours]

    Overall ERCP-related complations include PEP, bleeding, perforation, cholangitis and others, which is defined by Cotton's criteria.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Site City State Country Postal Code
1 Endoscopic center, Xijing Hospital of Digestive Diseases Xi'an Shaanxi China 710032

Sponsors and Collaborators

  • Air Force Military Medical University, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yanglin Pan, Associate Professor, Air Force Military Medical University, China
ClinicalTrials.gov Identifier:
NCT03707613
Other Study ID Numbers:
  • KY20180081-3
First Posted:
Oct 16, 2018
Last Update Posted:
Jan 27, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
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, Associate Professor, Air Force Military Medical University, China
ERCP
double guidewire technique
learning curve

Study Results

No Results Posted as of Jan 27, 2020