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A study to compare the success rate of two different techniques of accessing the bile duct using endoscopic ultrasound when standard ERCP technique fails in patients having biliary obstruction

Intrahepatic versus extrahepatic approach for endoscopic ultrasound guided rendezvous technique in patients with difficult biliary cannulation: a randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/078772
Enrollment
73
Registered
2024-12-30
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere

Interventions

Intervention1: Intrahepatic approach for endoscopic ultrasound guided rendezvous technique: When the standard ERCP fails, the patient who has been randomized into this arm will be taken up for the pro

Sponsors

Jayanta Samanta
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with naive papilla who require therapeutic ERCP Distal biliary obstruction with imaging features of intrahepatic biliary radicle dilatation Patients with difficult biliary cannulation, defined as per ESGE guidelines Informed consent for the participation in study

Exclusion criteria

Exclusion criteria: Patients with history of prior ERCP with papillary intervention Pregnant patient Hilar biliary obstruction Patients with surgically altered anatomy Patient hemodynamically unfit for endoscopic procedure Uncorrectable coagulopathy or thrombocytopenia Lack of informed consent

Design outcomes

Primary

MeasureTime frame
Technical success of intrahepatic and extrahepatic approach for EUS-guided rendezvous techniqueTimepoint: At baseline at the end of the index procedure

Secondary

MeasureTime frame
Overall complication rates Duration of the procedure Total radiation exposure during the procedure Pain score assessment using VAS score Analgesic requirement for any post procedure abdominal pain Salvage PTBD (percutaneous transhepatic biliary drainage) Hospital stay Timepoint: At 2 weeks post-procedure

Countries

India

Contacts

Public ContactJayanta Samanta

Postgraduate Institute of Medical Education and Research, Chandigarh

dj_samanta@yahoo.co.in09855319529

Outcome results

None listed

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