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Comparison of different techniques for bile duct intervention using endoscopic ultrasound and needle knife method

Endoscopic ultrasound guided rendezvous technique versus precut sphincterotomy as a salvage technique for difficult bile duct cannulation without inadvertent pancreatic duct cannulation: a randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/109042
Enrollment
260
Registered
2026-04-21
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: K839- Disease of biliary tract, unspecified Health Condition 2: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere

Interventions

Intervention1: Endoscopic ultrasound guided rendezvous technique (EUS-RV): When standard ERCP fails, the patient randomised to this arm will be taken up for the procedure. This technique will be perfo

Sponsors

Jayanta Samanta
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with naive papilla who require therapeutic ERCP Benign biliary diseases Extrahepatic biliary obstruction All patients with difficult biliary cannulation during as per ESGE guidelines who have any one of the following more than 5 contact with papilla while attempting to cannulate or more than 5 minutes spent to cannulate following visualisation of the papilla Informed consent for participation in the study

Exclusion criteria

Exclusion criteria: Previously sphincteromized papilla malignant biliary obstruction Hilar block past history of post ERCP pancreatitis inadvertant pancreatic duct cannulation or contrast injection unstable clinical conditions precluding EUS or ERCP pregnant patient lack of informed consent

Design outcomes

Primary

MeasureTime frame
To compare the rates of post ERCP pancreatitis between the two techniquesTimepoint: Within 2 weeks post procedure

Secondary

MeasureTime frame
Technical success overall adverse events Rate of serious adverse events Post procedure asymptomatic hyperamylasemia time taken to achieve deep biliary cannulation radiation expoure hospital stay need for second salvage procedure after failure of first salvage techniqueTimepoint: within 2 weeks of post procedure within 2 weeks of post procedure within 3-5 days post procedure

Countries

India

Contacts

Public ContactJayanta Samanta

Postgraduate Institute of Medical Education and Research

dj_samanta@yahoo.co.in9855319529

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026