RADIO FREQUENCY ABLATION IN UNRESECTABLE MALIGNANT BILIARY OBSTRUCTION

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.

Sex

All

Minimum age

18 Years

Maximum age

75 Years

Inclusion Criteria:

1. Age 18-75 years
2. Malignant biliary obstruction confirmed using computed tomography (CT) or abdominal magnetic resonance imaging(MRI), with pathological confirmation whenever possible;
3. Clinical jaundice, a serum bilirubin level greater than 5 mg/dL, and/or cholangitis;
4. ECOG performance status score≤2
5. Un resectability or refusal to be surgically treated.
6. Eligible patients were those with biliary obstruction due to cancer of the gallbladder, or bile ducts; who were considered unsuitable for surgery because of distant metastases, vascular invasion, or severe disability due to age or associated diseases.
7. Non-resectability was established through the consensus opinion of a multidisciplinary tumor board.
8. Written informed consent signed by the patient.

Exclusion Criteria:

• DERIVEDJagtap N, Kumar CS, Lakhtakia S, Ramchandani M, Memon SF, Asif S, Kalapala R, Nabi Z, Basha J, Gupta R, Tandan M, Reddy DN. Adjuvant endobiliary radio-frequency ablation combined with self-expandable biliary metal stents for unresectable malignant hilar strictures: A pragmatic comparative study. Indian J Gastroenterol. 2025 Feb;44(1):72-79. doi: 10.1007/s12664-024-01668-1. Epub 2024 Sep 6. PMID 39240508