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Completed

NCT Number: NCT03707613

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

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.

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Key information

Conditions

Biliary Cannulation Endoscopic Retrograde Cholangiopancreatography

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Endoscopic center, Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DWT learning curve

Procedure

trainees learn to perform DWT after unsuccessful initial cannulation

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 16, 2018
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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