Endoluminal Radiofrequency Ablation for the Treatment of Malignant Biliary Stenosis

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Brief Title

Endoluminal Radiofrequency Ablation for the Treatment of Malignant Biliary Stenosis

Official Title

Endoluminal Radiofrequency Ablation of Tumors Affecting the Bile Ducts

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.
    

Detailed Description

      The aim of this randomized study was to analyze survival rate in patients with malignant
      biliary obstruction treated with metal stent insertion with or without previous endoluminal
      radiofrequency ablation (RFA). Secondary endpoint was to analyze metal stent patency rate and
      survival rate in the subgroup of infiltrative hilar cholangiocarcinomas standardly treated by
      brachytherapy and metal stenting.

      All patients underwent percutaneous cholangiography followed by transhepatic drainage, all
      patients underwent histopathologic verification of the stenosis.

      Randomised patients in selected arm received endoluminal RFA by 8F catheter (Habib™ EndoHPB;
      EMcision Ltd., London, UK) before stenting procedure. Repeated ablations were processed
      through stenotic areas (10W, 90-120s, Rita 1500, Angiodynamics Ltd), all drained biliary
      tracts were used for introducing catheter and performance of ablation.

      In experimental group ablation procedure was followed with uncovered self-expandable metal
      stent insertion.

      Brachytherapy procedure (performed in case of cholangiocarcinoma as institutional treatment
      standard) was performed through 5F applicator by after loading system of iridium radiation
      source (HDR brachytherapy, applicator temporarily placed into a drain for 3-4 days).
      Prescribed dose was 15-24Gy at distance of 1.0cm in 3-4 fractions.

      Analyzed characteristics:

      Specific therapeutic procedures e.g. systemic chemotherapy, brachytherapy indicated by
      multidisciplinary tumor board were recorded. Laboratory tests were evaluated withing 24 hours
      before and after the RFA (AMS, INR, APTT, GMT, total bilirubin, ALP, ALT, AST). The time of
      initial diagnosis, drainage procedures, ablation and stenting were referred to patient
      survival. Patients underwent repeated ambulatory follow-up in 3months period (dedicated
      ultrasound performed by interventional radiologist, in case of bilirubin and obstructive
      enzymes elevation intensified follow up was performed). Patients time of death was gathered
      from record of central database of insured persons or from hospital information system.
      Procedural complications were graded in consensus by interventional radiologists and
      oncologist according to Common Terminology Criteria for Adverse Events.

      Primary stent patency:

      Stent patency was defined as the duration from the insertion of the stent until the date of
      closure. If the cause of death was directly related to stent failure, the date of death was
      defined as time of stent closure. If no stent failure occurred (i.e. the absence of increased
      total serum bilirubin levels or the absence of dilation of intrahepatic bile ducts on CT or
      US examination even if total serum bilirubin level was increased), stent patency was
      considered as censored at the date of death or at the end of the study period.

      Statistical methods:

      Analyses were performed using IBM SPSS Statistics 23 (IBM Corporation, Armonk, NY, USA).
      Basic characteristics were summarized by absolute and relative frequencies and compared using
      Fisher's exact test (categorical variables), continuous characteristics compared using the
      Mann-Whitney test. Survival parameters were evaluated by Kaplan-Meier methodology,
      differences in survival were evaluated by log-rank test. Relationships between survival
      parameters and endoluminal biliary pathway ablation prior to stent insertion were modelled
      using one-dimensional Cox regression models and described using a risk ratio (HR) of 95% CI
      for HR and a p-value corresponding to the relevant regression coefficient. The level of
      statistical significance in all analyses was set at α = 0.05.
    


Study Type

Interventional


Primary Outcome

Stent patency

Secondary Outcome

 Complications of endoluminal RFA of biliary tract

Condition

Radiofrequency Ablation

Intervention

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

Study Arms / Comparison Groups

 Experimental arm - endoluminal RFA
Description:  standard treatment protocol for malignant biliary stenosis + endoluminal RFA prior metal stent insertion

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

76

Start Date

January 4, 2010

Completion Date

December 31, 2019

Primary Completion Date

December 31, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  histologically verified malignant stenosis of bile ducts

          -  indication of implantation of SEMS by multidisciplinary indication committee

          -  signed informed consent

        Exclusion Criteria:

          -  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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Tomáš Andrašina, MD, , 

Location Countries

Czechia

Location Countries

Czechia

Administrative Informations


NCT ID

NCT04801719

Organization ID

FNBKRNM0002


Responsible Party

Principal Investigator

Study Sponsor

Brno University Hospital


Study Sponsor

Tomáš Andrašina, MD, Principal Investigator, Brno University Hospital


Verification Date

March 2021