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Modified Double Wire Technique to Facilitate the Successful Cannulation

Modified Double Wire Technique to Facilitate the Successful Cannulation: Prospective Randomized Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03413111
Enrollment
130
Registered
2018-01-29
Start date
2018-02-02
Completion date
2019-02-16
Last updated
2018-05-17

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

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 common bile duct (CBD) with a sphincterotome preloaded with another guidewire often becomes feasible. However, because of the small opening of the papilla, sometimes it is technically challenging for the following cannulation of CBD with the sphincterotome and PD guidewire in the same working channel. We hypothesized that a tiny cut of the opening of papilla, without the injury of pancreatic sphincter, may facilitate the success of DWT and shorten the overall cannulation time.

Interventions

PROCEDUREModified double wire technique

For experimental arm, a tiny cut of papilla orifice, with the length of 5mm, was performed by sphincterotome before the double wire cannulation.

Sponsors

Air Force Military Medical University, China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Patients aged 18-90 with native papilla; * CBD as the targeted duct; * Inadvertent PD cannulation more than twice; * Selective biliary cannulation was not possible within 10 minutes or 5 attempts.

Exclusion criteria

* Contraindications of ERCP; * Major or minor PD as the targeted duct; * NK or transpancreatic precut before enrollment ; * Surgically altered GI anatomy; * Papillary carcinoma or stone impaction within papilla or fistula in papilla; * Prior endoscopic sphincterotomy; * Complete pancreas divisum; * failure of pancreatic duct cannulation; * Pregnant or breastfeeding women; * Unwilling or inability to provide consent.

Design outcomes

Primary

MeasureTime frameDescription
Success rate of double wire technique3 hoursthe rate of successful cannulation of CBD for ≤5 attempts by using the sphincterotome alongside the PD guidewire.

Secondary

MeasureTime frameDescription
cannulation time of double wire technique3 hoursthe time taken from the touching of papilla by the sphincterotome alongside the PD guidewire to the successful cannulation of CBD
Number of attempts for the successful CBD cannulation3 hours
Overall cannulation success rate3 hours
complication rates48 hours

Countries

China

Contacts

Primary ContactPan Yanglin, M.D.
panyanglin@gmail.com+8613201851680

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026