RADIO FREQUENCY ABLATION IN UNRESECTABLE MALIGNANT BILIARY OBSTRUCTION

Phase

N/A

Condition

Gall Bladder Cancer

Bladder Cancer

Urothelial Cancer

Treatment

N/A

Clinical Study ID

NCT05320328

RFA

Ages 18-75
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age 18-75 years
Malignant biliary obstruction confirmed using computed tomography (CT) or abdominalmagnetic 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 thegallbladder, or bile ducts; who were considered unsuitable for surgery because ofdistant metastases, vascular invasion, or severe disability due to age or associateddiseases.
Non-resectability was established through the consensus opinion of a multidisciplinarytumor board.
Written informed consent signed by the patient.

Exclusion

Exclusion Criteria:

Study Design

June 10, 2021

December 10, 2022

Study 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.

Connect with a study center

Asian Institute of Gastroenterology
Hyderabad, Telangana 500082
India
Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.