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NCT05320328: MBOP

RADIO FREQUENCY ABLATION IN UNRESECTABLE MALIGNANT BILIARY OBSTRUCTION

Status unknown Last updated 11 April 2022
What this trial tests

trial testing Radio frequency ablation in Bile Duct Neoplasms in 50 participants. Status unknown.

Timeline
10 June 2021
Primary endpoint
10 June 2022
10 December 2022

Quick facts

Lead sponsorAsian Institute of Gastroenterology, India
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment50
Start date10 June 2021
Primary completion10 June 2022
Estimated completion10 December 2022
Sites1 location across India

Drugs / interventions tested

Conditions studied

Sponsor

Asian Institute of Gastroenterology, India

Who can join

Adults 18 to 75, any sex, with Bile Duct Neoplasms or Gall Bladder Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Endoscopic retrograde cholangio pancreatography procedure will performed as per local standard procedure.After common bile duct cannulation,cholangiography will be performed (to confirm the stricture) followed by biliary sphincterotomy. All biliary strictures(Bismuth Type I/II/III/IV) will be enrolled for the study. Patient opting for Uncovered self expandable metallic stent / Plastic stent will undergo biliary stent placement and considered under control arm Patient opting for radio frequency ablation + Uncovered SEMS/Plastic stent will undergo radio frequency ablation and biliary stent placement and considered under Study arm The RFA probe will be inserted into the bile duct alongwith the guidewire. Keeping the electrode overlapping the stricture, RFA will be performed using a power of 10W for 120 seconds. The electrode will be kept at the ablation site for an additional 1 minute to allow the RFA probe to cool before removal to prevent thermal injury of normal tissue and/or endoscope accessory channel. If the stricture is more than 3 cm, step-by-step RFA will be performed from the superior to inferior aspect. After RFA application, an uncovered SEMS/Plastic stent will be placed.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Adjuvant endobiliary radio-frequency ablation combined with self-expandable biliary metal stents for unresectable malignant hilar strictures: A pragmatic comparative study.
    Jagtap N, Kumar CS, Lakhtakia S, Ramchandani M, et al · · 2025 · cited 2× · PMID 39240508 · DOI 10.1007/s12664-024-01668-1

Verify or expand the search:

Other trials of Radio frequency ablation

Trials testing the same drug.

Other recruiting trials for Bile Duct Neoplasms

Currently open trials in the same condition.

Other Asian Institute of Gastroenterology, India trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05320328.

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