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Needle knife Fistulotomy for Biliary Cannaulation in Patients with High Risk of Post-ERCP Pancreatitis

Primary Needle Knife Fistulotomy for Biliary Cannulation in Patients with High Risk of Post-ERCP Pancreatitis; A Single Arm, Multicenter, Prospective Pilot Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0006387
Enrollment
150
Registered
2021-07-27
Start date
2021-03-17
Completion date
Unknown
Last updated
2021-08-30

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

Conditions

None listed

Interventions

None listed

Sponsors

Inha University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with naive papilla 2. Patients with 1 or more post-ERCP pancreatitis 1) suspected sphincter of Oddi dysfunction 2) age 18-50 years 3) female 4) normal common bile duct diameter (= 9mm) 5) normal serum bilirubin 6) body mass index >30 kg/m2 7) Hx of acute pancreatitis

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Contrast agent hypersensitivity 3. previous sphincterotomy 4. tumor at Ampulla of Vater 5. anticipated difficult approach to the ampulla because of previous abdominal surgery 6. pancreatic disorders 1)acutepancreatitis within the past 30 days 2)idiopathic acute recurrent pancreatitis 3)pancreas divisum, 4)obstructive chronic pancreatitis 5)pancreatic cancer 7. Abnormal papilla 1)small, flat, crooked, or asymmetric papilla 2)papilla with periampullary diverticulum type I or II

Design outcomes

Primary

MeasureTime frame
Incidence of post-ERCP pancreattis—

Secondary

MeasureTime frame
Success rate of selective biliary cannulation—

Countries

Korea, Republic of

Contacts

Public ContactSung Woo Ko

The Catholic University of Korea, Eunpyeong St. Mary's Hospital

gogo930@catholic.ac.kr+82-2-2030-4595

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026