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Efficacy of Needle knife-precut fistulotomy versus precut using Iso-Tome in difficult biliary cannulation

Efficacy of Needle knife-precut fistulotomy versus precut using Iso-Tome in difficult biliary cannulation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0001960
Enrollment
218
Registered
2016-07-04
Start date
2015-11-05
Completion date
Unknown
Last updated
2019-03-11

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

Conditions

None listed

Interventions

Medical Device : ERCP procedure for this study is carried out by two endoscopist with more than 5 years of experience. Procedure is overnight fast after IV midazolam (0.05 mg / kg) or propofol (0.5 mg
Olympus Optical Co . Ltd., utilizes Tokyo, Japan). First, standard wire-guided if the technique progress bile duct intubation in the attempted a papillary contacts at least five times or more than 5 m
re trying to expose the bile duct intubation after intrapapillary mucosa incision from the orifice of the AV using the needle-knife (Microtome Boston Scientific, Microvasive, Marlboro, MA). The incisi
uses (UES-30 generator Olympus). If the bile duct intubation unsuccessful, repeat the ERCP followed by 1 to 3 days after. The results of treatment are invesgated by recording and analysis.

Sponsors

Soon Chun Hyang University Hospital Cheonan
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: By naive ERCP in patients with standard catheter or guidewire technique fails bile duct cannulation in patients undergoing conventional method using a precut fistulotomy.

Exclusion criteria

Exclusion criteria: (1) 18? ?? (2) surgically altered anatomy (Billroth II gastrectomy, Roux-en-Y anastomosis ?) (3) prior biliary or pancreatic sphincterotomy (4) Uncontrolled coagulopathy (5) Refusal to this study

Design outcomes

Primary

MeasureTime frame
technical success

Secondary

MeasureTime frame
Complications

Countries

Korea, Republic of

Contacts

Public ContactTae Hoon Lee

Soon Chun Hyang University Hospital Cheonan

taewoolee9@gmail.com+82-41-570-3662

Outcome results

None listed

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