Prospective Evaluation of the Ablation Therapy With Bipolar Radio Frequency for Nonresectable Bile Duct Cancer

NCT03679338 | Completed Phase 2

• 1 other identifier: RFA-BILIAIRE-IPC 2016-003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

90 % of the patients with bile duct cancer are not justifiable of a surgical resection with curative aim for oncologic reasons ( metastatic extensions), for reasons of resectability (canalar extension, vascular) or still for surgically reasons (age, comorbidity). The palliative care of these patients consists at first in assuring an effective biliary drainage, infectious complications being one of the main causes of death. The biliary drainage allows to improve the survival of these patients. It bases by the implementation, by the endoscopic or percutaneous way of biliary, generally metallic prosthesis the duration of average permeability of which is of approximately 6 months. The standard oncologic treatment is the administration of a chemotherapy exclusive or associated with a radiotherapy. The radiotherapy and the radio chemotherapy did not show efficiency on the survival superior to the exclusive biliary drainage. The first-line exclusive chemotherapy bases on the gemcitabine-cisplatin association with a median survival of 11,6 months. No study allows to justify the administration of a chemotherapy of the second line. Thus the preservation of the permeability of the biliary ways is today, the most important factor to improve the survival of these patients. Therefore, the addition of a treatment allowing to obtain a local tumoral response to the insertion of biliary prosthesis would allow to increase the duration of permeability of the biliary prosthesis and would limit the local evolution. Endoductal destruction tumoral technics were thus developed in this indication:

1. 1.Dynamic phototherapy which demonstrated, during preliminary studies, a certain efficiency both on the tumoral response estimated on the improvement of the tumoral stenosis as on the survival in case of cholangiocarcinoma bile ducts not resectables. However, the improvement of the survival was not confirmed by wider randomized studies. A study randomized of phase III was interrupted prematurely because of a survival decreased in the experimental arm.
2. 2.The radium therapy and the brachytherapy were estimated in this indication with results interesting on series limited in size, but is not used in routine because of its cost and of technics difficulties.

Conditions

Nonresectable Bile Duct Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of success of the use of a treatment based on radiofrequency for all the target stenosis.

  Evaluation of the success of the use of bipolary radiofrequency for all target stenosis after each procedure

  1 day

Secondary Outcomes (5)

• Technic efficiency (Measure the duration of biliary permeability in the time)

  From date of end of the treatment and the date of the first one re-permeabilisation of the prosthesis (until end of follow-up: 1 year)

• Number of intervention for biliary drainage on the duration of the follow-up

  From day of intervention until follow-up (during 1 year)

• Global morbidity to 30 days

  From day of intervention until 30 days

• Specific morbidity to 30 days

  From day of intervention until 30 days

• Overall survival

  From day of intervention until 12 months

Study Arms (1)

Ablation Therapy With Bipolar Radio Frequency

OTHER

Device: Ablation Therapy

Interventions

Ablation Therapy DEVICE

Ablation Therapy With Bipolar Radio frequency

Ablation Therapy With Bipolar Radio Frequency

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years,
• Bile duct cancer nonresectable
• Type I, II ou III of Bismuth classification with cholangio-MRI and/or endoscopic cholangiography
• Laboratory values : prothrombin time ≥ 50%, platelets ≥ 50 000, aPTT \< 3 (Authorized transfusions)
• Written informed consent,
• Affiliation to Social Security System.

You may not qualify if:

• Intra-pancreatic mass and/or Wirsung dilation,
• Bile duct cancer,
• Visceral metastasis (extrahepatic),
• Initial metallic prosthesis,
• Woman pregnant or susceptible to the being,
• Patients deprived of liberty or placed Under the authority of a tutor,
• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (1)

Institut Paoli-Calmettes

Marseille, 13009, France

Location

Related Links

• Institut Paoli-Calmettes

Study Officials

• BORIES Erwan, MD

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: September 20, 2018
• Study Start: March 22, 2018
• Primary Completion: March 18, 2021
• Study Completion: March 11, 2022
• Last Updated: June 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)