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Safety of early precut fistulotomy in ERCP

Success rates in patients undergoing selective biliary cannulation: A randomized study comparing Early versus late precut fistulotomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/04/018618
Enrollment
40
Registered
2019-04-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: K831- Obstruction of bile duct

Interventions

Intervention1: Precut sphincterotomy: Comparing early versus late precut fistulotomy for difficult biliary cannulation Control Intervention1: Early versus late precut sphincterotomy: Early versus late

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with difficult cannulation ( > 5 minutes without selective contrast free biliary cannulation)

Exclusion criteria

Exclusion criteria: 1- Altered anatomy- Billroth II 2- Periampullary diverticulum 3- Coagulopathy- INR >1.5 4- Suspected periampullary growth 5- Very small/flat papilla

Design outcomes

Primary

MeasureTime frame
Success rate of selective biliary cannulationTimepoint: 2 years—

Secondary

MeasureTime frame
1- Complication rate 2- Fluoroscopy time 3- Need for repeat ERC 4- Need for other interventionsTimepoint: 2 years—

Countries

India

Contacts

Public ContactHARSHAL SURENDRA MANDAVDHARE

POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH

hmandavdhare760@gmail.com9592814877

Outcome results

None listed

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