Prospective Evaluation of the Ablation Therapy With Bipolar Radio Frequency for Nonresectable Bile Duct Cancer (RFA-BILIAIRE)

• ClinicalTrials.gov Identifier: NCT03679338
• Recruitment Status: Active, not recruiting
• First Posted: September 20, 2018
• Last Update Posted: May 6, 2021
• Sponsor: Institut Paoli-Calmettes
• Information provided by (Responsible Party): Institut Paoli-Calmettes

Study Description

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. 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. 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.

Ablation therapy technics (radio frequency, microwaves, radium therapy) percutaneous by radiological or surgical way proved their efficiency for the treatment of hepatocarcinoma and liver metastasis.

The hepatic radio frequency was estimated, during trials of phases II, for peripheral cholangiocarcinoma intra hepatic (developed at a distance main bile ducts) with interesting tumoral rates of necrosis.

However, the direct percutaneous access of the cholangiocarcinoma of the biliary ways is not practicable because of the risk of iatrogenic biliary fistula.

Therefore, systems allowing to realize ablation therapy by endoductal radio frequency are from now on available. It is miniaturized bipolar probes which are inserted into bile ducts by reactionary way (retrograde cholangiography), or anterograde percutaneous.

Two systems (Habib ®, ELLRA ®) are at present available and were estimated during in vitro and in vivo studies, to the animal and in man.

The purposes of this study are to estimate the feasibility, the efficiency and the morbidity of the biliary radio frequency for the treatment of the extra hepatic cholangiocarcinoma non resectable (resection or transplantation).

Condition or disease	Intervention/treatment	Phase
Nonresectable Bile Duct Cancer	Device: Ablation Therapy	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective Evaluation of the Ablation Therapy With Bipolar Radio Frequency for Nonresectable Bile Duct Cancer
• Actual Study Start Date: March 22, 2018
• Actual Primary Completion Date: March 18, 2021
• Estimated Study Completion Date: March 2022

Arms and Interventions

Arm	Intervention/treatment
Ablation Therapy With Bipolar Radio Frequency	Device: Ablation Therapy; Ablation Therapy With Bipolar Radio frequency

Outcome Measures

Primary Outcome Measures :

1. Rate of success of the use of a treatment based on radiofrequency for all the target stenosis. [ Time Frame: 1 day ]
   Evaluation of the success of the use of bipolary radiofrequency for all target stenosis after each procedure

Secondary Outcome Measures :

1. Technic efficiency (Measure the duration of biliary permeability in the time) [ Time Frame: 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) ]
   Ablation Therapy
2. Number of intervention for biliary drainage on the duration of the follow-up [ Time Frame: From day of intervention until follow-up (during 1 year) ]
   Biliary drainage intervention
3. Global morbidity to 30 days [ Time Frame: From day of intervention until 30 days ]
   Morbidity
4. Specific morbidity to 30 days [ Time Frame: From day of intervention until 30 days ]
   Complications after intervention((cholecystitis, haemorrhage, pancreatitis, angiocholitis, intestinal perforation),
5. Overall survival [ Time Frame: From day of intervention until 12 months ]
   Overall survival

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

France

Institut Paoli-Calmettes

Marseille, France, 13009

Sponsors and Collaborators

Institut Paoli-Calmettes

Investigators

• Principal Investigator: BORIES Erwan, MD; Institut Paoli-Calmettes

More Information

Additional Information:

Institut Paoli-Calmettes 

• Responsible Party: Institut Paoli-Calmettes
• ClinicalTrials.gov Identifier: NCT03679338
• Other Study ID Numbers: RFA-BILIAIRE-IPC 2016-003
• First Posted: September 20, 2018
• Last Update Posted: May 6, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Bile Duct Neoplasms; Cholangiocarcinoma; Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type