NCT03679338: RFA-BILIAIRE

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

Completed Phase 2 Last updated 23 June 2023

What this trial tests

Phase 2 trial testing Ablation Therapy in Nonresectable Bile Duct Cancer in 20 participants. Completed in 11 March 2022.

Timeline

22 March 2018

Primary endpoint
18 March 2021

11 March 2022

Quick facts

Lead sponsor	Institut Paoli-Calmettes
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	22 March 2018
Primary completion	18 March 2021
Estimated completion	11 March 2022
Sites	1 location across France

Drugs / interventions tested

• Ablation Therapy

Conditions studied

• Nonresectable Bile Duct Cancer — all drugs for Nonresectable Bile Duct Cancer →

Sponsor

Institut Paoli-Calmettes — full company profile →

Who can join

18 and older, any sex, with Nonresectable Bile Duct Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Update on Locoregional Therapies for Cholangiocellular Carcinoma.
   Morawitz J, Bruckmann NM, Jannusch K, Kirchner J, et al · · 2023 · cited 5× · PMID 37190295 · DOI 10.3390/cancers15082368