CompletedNot Applicable

Primary Needle Knife Fistulotomy Versus Conventional Cannulation Method

South Korea207 participantsStarted 2016-10-04

Plain-language summary

The aim of this study are to evaluate the feasibility of needle knife fistulotomy (NKF) as an initial procedure for biliary access in patients with biliary disease who are at increased risk for post-endoscopic retrograde endoscopic retrograde cholangiopancreatography (PEP) and to assess the incidence rate of complications including PEP between NKF and conventional cannulation methods.

Who can participate

Age range19 Years – 90 Years

SexALL

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Inclusion criteria

✓. suspected biliary sphincter of Oddi dysfunction
✓. young age (18\~50 years)
✓. female
✓. normal common bile duct diameter (≤9mm)
✓. normal serum bilirubin level
✓. Obesity (body mass index \> 30)
✓. Past history of acute pancreatitis

Exclusion criteria

✕. Patient who have acute pancreatitis within 30days before enrollment
✕. Patient who have idiopathic acute recurrent pancreatitis
✕. Patient who have pancreatic divisum
✕. Patient who have obstructive chronic pancreatitis
✕. Patient who pancreatic cancer
✕. Small ampulla (ampulla without oral protrusion)
✕. Flat or crooked or asymmetric ampulla
✕. Ampulla with peri-ampullary diverticulum type I or II

What they're measuring

Incidence rate of post-endoscopic retrograde cholangiopancreatography

Timeframe: 1 week

Trial details

NCT IDNCT02916199

SponsorGangnam Severance Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-11-28

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