RADIO FREQUENCY ABLATION IN UNRESECTABLE MALIGNANT BILIARY OBSTRUCTION (MBOP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bile Duct Neoplasms; Gall Bladder Carcinoma
• Intervention / Treatment: Device: Radio frequency ablation

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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Sai Dr Kumar, MBBS MD; Phone Number: 9121792373; Email: saiaig21@gmail.com
• Study Contact Backup: Name: Rajesh Mr Goud, M.Pharma, MBA, PDCR; Phone Number: 9705053550; Email: rajeshgoud761@gmail.com

Study Locations

• India
  • Telangana
    • Hyderabad, Telangana, India, 500082
      • Recruiting
      • Asian Institute of Gastroenterology
      • Contact: Rajesh Goud, M.Pharma MBA; Phone Number: 040 23378888; Email: rajeshgoud761@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

50 Subjects

Description

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:

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.; Other Names: RFA
2; The control group (B) will receive uncovered Self expandable metal stent / Plastic stent (one or more) placement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent patency at 1 year	Stent patency will be estimated by bio chemical parameters (Total bilirubin, Alkaline phosphatase) or ultra sound abdomen scan	12 months

Collaborators and Investigators

• Sponsor: Asian Institute of Gastroenterology, India

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2021
• Primary Completion (Anticipated): June 10, 2022
• Study Completion (Anticipated): December 10, 2022

Study Registration Dates

• First Submitted: March 23, 2022
• First Submitted That Met QC Criteria: April 1, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2022
• Last Update Submitted That Met QC Criteria: April 1, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Digestive System Neoplasms; Biliary Tract Diseases; Bile Duct Diseases; Biliary Tract Neoplasms; Urinary Bladder Neoplasms; Bile Duct Neoplasms
• Other Study ID Numbers: RFA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No