Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04801719
Other study ID # FNBKRNM0002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 4, 2010
Est. completion date December 31, 2019

Study information

Verified date March 2021
Source Brno University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Czechia Brno University Hospital Brno

Sponsors (1)

Lead Sponsor Collaborator
Brno University Hospital

Country where clinical trial is conducted

Czechia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Complications of endoluminal RFA of biliary tract Procedural complications were graded in consensus by interventional radiologists and oncologist according to Common Terminology Criteria for Adverse Events v4.0. up to day 30
See also
  Status Clinical Trial Phase
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Withdrawn NCT03110510 - FOLFIRI as Salvage Treatment in Metastatic Biliary Tract Cancer (BTC) Patients Who Were Failed After Gemcitabine Containing Chemotherapy: A Phase II Single Arm Prospective Study Phase 2
Completed NCT05116891 - A Phase 1/2 Study of CAN04 in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumors Phase 1/Phase 2
Completed NCT00380588 - Randomized Phase 2 Study With Gemcitabine Alone and Combination Therapy for Patients With Advanced Biliary Tract Cancer Phase 2
Terminated NCT00090025 - XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors Phase 3
Terminated NCT04066491 - Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC Phase 2/Phase 3
Recruiting NCT05998447 - GEN-001 Plus Pembrolizumab for Patients With Advanced Refractory Biliary Tract Cancer Phase 2
Recruiting NCT03718897 - Identification of Prognostic Gene Mutations in Biliary Tract Cancer Using Whole Genome Sequencing
Recruiting NCT05056116 - A Safety and Efficacy Study of Surufatinib Combination With Toripalimab in Patients With Recurrent Biliary Tract Cancer N/A
Recruiting NCT04692051 - A Phase II Study for Nab-paclitaxel Plus Cisplatin vs Gemcitabine Plus Cispatin as First Line Chemotherapy in Advanced Biliary Tract Cancer Phase 2
Terminated NCT04057365 - Study of the Combination of DKN-01 and Nivolumab in Previously Treated Patients With Advanced Biliary Tract Cancer (BTC) Phase 2
Recruiting NCT04907643 - Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes N/A
Completed NCT02829918 - Study of Nivolumab in Patients With Advanced Refractory Biliary Tract Cancers Phase 2
Recruiting NCT04584996 - CIRcular and Non-coding RNAs as Clinically USeful Biomarkers in Pancreaticobiliary Cancers
Completed NCT02579616 - Study of Lenvatinib (E7080) in Unresectable Biliary Tract Cancer (BTC) Who Failed Gemcitabine-based Combination Chemotherapy Phase 2
Recruiting NCT05052099 - Phase Ib/II Single-arm Study of mFOLFOX6, Bevacizumab and Atezolizumab in Advanced Biliary Tract Cancer Phase 1/Phase 2
Recruiting NCT01494363 - Phase II Study of FOLFOXIRI in Patients With Locally Advanced or Metastatic Biliary Tract Cancer Phase 2
Completed NCT00753675 - Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer Phase 2
Terminated NCT00630890 - Cyberknife Radiosurgery Boost for Hilar Cholangiocarcinoma (Klatskin Tumor) Phase 1
Recruiting NCT04445532 - Hepatobiliary Tumors Tissue Samples Acquisition