NCT05320328

RADIO FREQUENCY ABLATION IN UNRESECTABLE MALIGNANT BILIARY OBSTRUCTION

SAFETY AND EFFICACY OF INTRA DUCTAL RADIO FREQUENCY ABLATION IN UNRESECTABLE MALIGNANT BILIARY OBSTRUCTION: PROSPECTIVE OBSERVATIONAL STUDY

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Asian Institute of Gastroenterology, India · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

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.

Detailed description

Placement of self expandable metallic stent is the standard of care in the palliative management of patients with malignant biliary strictures . Relieves biliary obstruction and jaundice. Self expandable metallic stent provide efficient drainage and have superior patency rates compared with the plastic stents Endoscopic radio frequency ablation combined with stent placement can significantly prolong survival and the stent patency period without increasing the incidence of adverse events in patients with extra hepatic cholangiocarcinoma patient. Compared to plastic/ metal stent placement alone the addition of radio frequency ablation to stent placement would have better outcomes.

Conditions

• Bile Duct Neoplasms
• Gall Bladder Carcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-06-10
• Primary completion: 2022-06-10
• Completion: 2022-12-10
• First posted: 2022-04-11
• Last updated: 2022-04-11

Locations

1 site across 1 country: India