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RADIO FREQUENCY ABLATION IN UNRESECTABLE MALIGNANT BILIARY OBSTRUCTION

NCT05320328 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2022-04-11

No results posted yet for this study

Summary

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.

Conditions

  • Bile Duct Neoplasms
  • Gall Bladder Carcinoma

Interventions

DEVICE

Radio frequency ablation

Radiofrequency ablation (RFA) uses heat to kill cancer cells. High-frequency electrical currents are passed through a special needle or probe called a needle electrode. The electrical current from the probe heats a small area containing cancer cells to high temperatures, killing the cancer cells. The area around the tumour is also usually treated because it may contain cancer cells.

Sponsors & Collaborators

  • Asian Institute of Gastroenterology, India

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-10
Primary Completion
2022-06-10
Completion
2022-12-10

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05320328 on ClinicalTrials.gov