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Precut sphincterotomy versus Endoscopic ultrasonography guided rendezvous technique for distal biliary malignancy

Randomized study of precut sphincterotomy versus Endoscopic ultrasonography guided rendezvous technique (EUS-RV) among patients with failed cannulation for distal biliary malignancy during endoscopic retrograde cholangiopancreaticography

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/06/019752
Enrollment
72
Registered
2019-06-19
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: C15-C26- Malignant neoplasms of digestive organs

Interventions

Intervention1: Precut sphincterotomy group: Precut sphincterotomy consists of an incision in the papilla in the absence of free biliary cannulation. The incision is performed most frequently with a ne

Sponsors

Endoscopy Research Foundation
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either sex aged 18-70 years 2. Patients with distal bile duct malignant obstruction with a failed cannulation during ERCP 3. Patients who sign the informed consent form

Exclusion criteria

Exclusion criteria: 1. Patients with duodenal obstruction, inflammatory head mass of pancreas 2. Patients with an inaccessible ampulla of Vater 3. Surgically altered anatomy precluding ERCP 4. Pregnancy 5. Past history of pancreatic surgery or other malignancy

Design outcomes

Primary

MeasureTime frame
Technical success and Clinical successTimepoint: At end of study

Secondary

MeasureTime frame
Secondary outcomes include -Procedure time, number of procedures and adverse eventsTimepoint: At end of study

Countries

India

Contacts

Public ContactDr Amit Maydeo

Baldota Institute of Digestive Sciences

amitmaydeo@gmail.com02267670311

Outcome results

None listed

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