Clinical trial NCT05320328: RADIO FREQUENCY ABLATION IN UNRESECTABLE MALIGNANT BILIARY OBSTRUCTION
Official title: SAFETY AND EFFICACY OF INTRA DUCTAL RADIO FREQUENCY ABLATION IN UNRESECTABLE MALIGNANT BILIARY OBSTRUCTION: PROSPECTIVE OBSERVATIONAL STUDY
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bile Duct Neoplasms
Gall Bladder Carcinoma
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 50 Subjects

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.

Eligibility criteria: 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:

Primary outcomes:
measure: Prospectively evaluate the safety and efficacy of combining intraductal Radio frequency ablation with biliary metal/ plastic stent placement for patients with malignant biliary obstruction.
timeFrame: 12 months
Secondary outcomes:
measure: Stent patency at 1 year
timeFrame: 12 months
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology
state: Telangana
Study officials:
References: