Endoluminal Radiofrequency Ablation for the Treatment of Malignant Biliary Stenosis

NCT04801719 | Completed

• 1 other identifier: FNBKRNM0002
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The rationale of the study is to explore the safety and efficacy of endoluminal radiofrequency ablation prior metal stent insertion in patiens with malignant biliary stenosis.

Conditions

Radiofrequency Ablation; Biliary Tract Cancer; Stent Complication; Brachytherapy

Outcome Measures

Primary Outcomes (2)

• Stent patency

  Analysis of metal stent patency since insertion in both study arms (measured in months, Kaplan-Meier estimate).

  up to month 36 or death of the patient

• Overall survival

  Analysis of overall survival since the diagnosis, initial drainage, and metal stent insertion in both study arms (measured in months, Kaplan-Meier estimate).

  up to month 36 or death of the patient

Secondary Outcomes (1)

• Complications of endoluminal RFA of biliary tract

  up to day 30

Study Arms (2)

Experimental arm - endoluminal RFA

EXPERIMENTAL

standard treatment protocol for malignant biliary stenosis + endoluminal RFA prior metal stent insertion

Device: Habib™ EndoHPB; Boston Scientific, US; former EMcision Ltd., UK

Control arm

NO INTERVENTION

standard treatment protocol for malignant biliary stenosis which includes metal stent insertion

Interventions

Habib™ EndoHPB; Boston Scientific, US; former EMcision Ltd., UK DEVICE

Randomised patients in selected arm received endoluminal RFA by 8F catheter (Habib™ EndoHPB; Boston Scientific, US; former EMcision Ltd., UK) before stenting procedure. Repeated ablations were processed through stenotic areas of bile ducts (10W, 90-120s, Rita 1500, Angiodynamics Ltd), all drained biliary tracts were used for introducing catheter and performance of ablation. Ablation procedure was followed with uncovered self-expandable metal stent insertion.

Experimental arm - endoluminal RFA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically verified malignant stenosis of bile ducts
• indication of implantation of SEMS by multidisciplinary indication committee
• signed informed consent

You may not qualify if:

• life expectancy of less than 3 months
• Karnofsky performance status of \<80%
• history or concomitant treatment with intraarterial oncologic therapies (eg, hepatic arterial infusion, chemoembolization)
• ongoing infections resistant to antibiotic therapy
• clinical or biochemical signs of liver or renal failure
• INR ≥ 1.3, serum albumin ≤ 35 g/l, haemoglobin ≤ 100 g/l, serum creatinine ≥ 200μmol/l

Sponsors & Collaborators

• Brno University Hospital: lead

Study Sites (1)

Brno University Hospital

Brno, 62500, Czechia

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Tomáš Andrašina, MD

  Brno University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tomáš Andrašina, MD, PhD; Assistant professor, Head of Non-vascular interventions and Computed Tomography of the Department of Radiology and Nuclear Medicine

Model Details: Two study arms with histologically proven malignant biliary stenosis treated either by endoluminal radiofrequency ablation with subsequent metal stent insertion or metal stent insertion only.

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 17, 2021
• Study Start: January 4, 2010
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)