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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03707613
Enrollment
60
Registered
2018-10-16
Start date
2018-10-15
Completion date
2019-09-29
Last updated
2020-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Cannulation, Endoscopic Retrograde Cholangiopancreatography

Keywords

ERCP, double guidewire technique, learning curve

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.

Interventions

PROCEDUREDWT learning curve

trainees learn to perform DWT after unsuccessful initial cannulation

Sponsors

Air Force Military Medical University, China
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Successful cannulation of bile duct within 5min or 5 attempts of cannulation3 hoursIt was defined by assurance of entering bile duct through cholangiogram during fluoroscopy.

Secondary

MeasureTime frameDescription
Successful cannulation time with DWT by trainees3 hoursSuccessful cannulation time was defined by the time taken from the begining of DWT to entering bile duct successfully
Cannulation attempts with DWT by trainees3 hoursOne cannulation attempt was defined by touching papilla for more than 5 seconds.
Precut rate3 hoursPrecut includes the procedure of cannulation involving needle knife or dual knife and transpancreatic precut by a sphincterotome.
post-ERCP pancreatitis(PEP)48 hoursPEP is defined according to Cotton's criteria. The severity classification is based on revised Atlanta criteria.
Overall ERCP-related complications48 hoursOverall ERCP-related complations include PEP, bleeding, perforation, cholangitis and others, which is defined by Cotton's criteria.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026