Status:
UNKNOWN
RADIO FREQUENCY ABLATION IN UNRESECTABLE MALIGNANT BILIARY OBSTRUCTION
Lead Sponsor:
Asian Institute of Gastroenterology, India
Conditions:
Bile Duct Neoplasms
Gall Bladder Carcinoma
Eligibility:
All Genders
18-75 years
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)...
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 expand...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 10 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 10 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05320328
Start Date
June 10 2021
End Date
December 10 2022
Last Update
April 11 2022
Active Locations (1)
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1
Asian Institute of Gastroenterology
Hyderabad, Telangana, India, 500082