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

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ClinicalTrials.gov Identifier: NCT03707613
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
Yanglin Pan, Fourth Military Medical University

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.


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

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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




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.



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Ages Eligible for Study:   18 Years to 90 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707613


Contacts
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Contact: Yanglin Pan, M.D. +8613201851680 panyanglin@gmail.com

Locations
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China, Shaanxi
Endoscopic center, Xijing Hospital of Digestive Diseases Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Yanglin Pan, M.D.    86-29-84771536    panyl@fmmu.edu.cn   
Principal Investigator: Yanglin Pan, M.D.         
Sponsors and Collaborators
Fourth Military Medical University

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Responsible Party: Yanglin Pan, Associate Professor, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT03707613     History of Changes
Other Study ID Numbers: KY20180081-3
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Yanglin Pan, Fourth Military Medical University:
ERCP
double guidewire technique
learning curve