RADIO FREQUENCY ABLATION IN UNRESECTABLE MALIGNANT BILIARY OBSTRUCTION

NCT05320328 | Unknown DMC

• 1 other identifier: RFA
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Prospectively evaluate the safety and efficacy of combining intraductal Radio frequency ablation with biliary metal/ plastic stent placement for patients with malignant biliary obstruction.

  satety of radio frequency ablation assessed by complications/adverse effects post procedure and efficacy of the procedure will be assessed by stent patency at the end of one month

  12 months

Secondary Outcomes (1)

• Stent patency at 1 year

  12 months

Study Arms (2)

1

The study group (A) will receive radio frequency ablation followed by uncovered Self expandable metal stent/Plastic stent placement (one or more)at same procedure.

Device: Radio frequency ablation

2

The control group (B) will receive uncovered Self expandable metal stent / Plastic stent (one or more) placement.

Interventions

Radio frequency ablation DEVICE

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.

Also known as: RFA

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

50 Subjects

You may qualify if:

• Age 18-75 years
• Malignant biliary obstruction confirmed using computed tomography (CT) or abdominal magnetic resonance imaging(MRI), with pathological confirmation whenever possible;
• Clinical jaundice, a serum bilirubin level greater than 5 mg/dL, and/or cholangitis;
• ECOG performance status score≤2
• Un resectability or refusal to be surgically treated.
• 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.
• Non-resectability was established through the consensus opinion of a multidisciplinary tumor board.
• Written informed consent signed by the patient.

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian Institute of Gastroenterology

Hyderabad, Telangana, 500082, India

RECRUITING

Related Publications (1)

• Jagtap 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 DERIVED

MeSH Terms

Conditions

Bile Duct Neoplasms; Gallbladder Neoplasms

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Sai Dr Kumar, MBBS MD

CONTACT

9121792373; saiaig21@gmail.com

Rajesh Mr Goud, M.Pharma, MBA, PDCR

CONTACT

9705053550; rajeshgoud761@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 11, 2022
• Study Start: June 10, 2021
• Primary Completion: June 10, 2022
• Study Completion: December 10, 2022
• Last Updated: April 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)