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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05320328
Acronym
MBOP
Enrollment
50
Registered
2022-04-11
Start date
2021-06-10
Completion date
2022-12-10
Last updated
2022-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bile Duct Neoplasms, Gall Bladder Carcinoma

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.

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.

Interventions

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

Asian Institute of Gastroenterology, India
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 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.

Design outcomes

Primary

MeasureTime frameDescription
Prospectively evaluate the safety and efficacy of combining intraductal Radio frequency ablation with biliary metal/ plastic stent placement for patients with malignant biliary obstruction.12 monthssatety 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

Secondary

MeasureTime frameDescription
Stent patency at 1 year12 monthsStent patency will be estimated by bio chemical parameters (Total bilirubin, Alkaline phosphatase) or ultra sound abdomen scan

Countries

India

Contacts

Primary ContactSai Dr Kumar, MBBS MD
saiaig21@gmail.com9121792373
Backup ContactRajesh Mr Goud, M.Pharma, MBA, PDCR
rajeshgoud761@gmail.com9705053550

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026