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To compare which of the three salvage techniques of ERCP is better than the other in cases which need bile duct drainage

Comparison of precut sphincterotomy, double guidewire technique and trans-pancreatic sphincterotomy as salvage techniques for management of patients with difficult biliary cannulation due to inadvertent pancreatic duct cannulation: triple arm randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/109622
Enrollment
400
Registered
2026-04-28
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Interventions

Intervention1: Precut Sphincterotomy: In this technique, a free hand incision is made using needle knife sphincterotome, starting to give incision over the previously placed pancreatic duct stent. Thi

Sponsors

Jayanta Samanta
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Benign or malignant biliary disease with naive papilla who require therapeutic ERCP Distal extrahepatic biliary obstruction All patients with difficult biliary cannulation, defined as per ESGE guideline with more than one inadvertent pancreatic duct cannulation or opacification The patient who gives informed consent for participation in the study

Exclusion criteria

Exclusion criteria: Previously sphincteromized papilla Difficult biliary cannulation defined as per ESGE guidelines who have more than 5 contact with papilla while attempting to cannulate or more than 5 minutes spent to cannulate following visualisation of the papilla Past history of post-ERCP pancreatitis Chronic pancreatitis Cases where pancreatic stent was placed for therapeutic intent like pancreatic leak or PD stricture Patients supposed to undergo ampullectomy Pregnant patients Unstable clinical conditions or any contraindication for ERCP Lack of informed consent

Design outcomes

Primary

MeasureTime frame
Technical success of the endoscopic procedureTimepoint: At the time of index procedure

Secondary

MeasureTime frame
Rates of post ERCP pancreatitis (PEP) Overall adverse events rates Time taken for the procedure Radiation exposure Hospital stay Need of second salvage procedure or PTBD or surgery after failure of first salvage technique Timepoint: at 2 weeks and 1 month post endoscopic intervention

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: Jun 11, 2026