Nonresectable Bile Duct CancerPhase 2RFA-BILIAIRENCT03679338
Prospective Evaluation of the Ablation Therapy With Bipolar Radio Frequency for Nonresectable Bile Duct Cancer
A Phase 2 study testing Ablation Therapy in people with Nonresectable Bile Duct Cancer, run by Institut Paoli-Calmettes at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonresectable Bile Duct Cancer
- What is being tested?
- Ablation Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 22 Mar 2018to 11 Mar 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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:
- 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.
- 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).
- Conditions
- Nonresectable Bile Duct Cancer
- Being tested
- Ablation Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablation TherapyDevice
Ablation Therapy With Bipolar Radio frequency
| Study group | Role | What they receive |
|---|---|---|
| Ablation Therapy With Bipolar Radio Frequency | Other | Not described Receives: Device: Ablation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (5)
Technic efficiency (Measure the duration of biliary permeability in the time)
Ablation Therapy
Measured: 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
Biliary drainage intervention
Measured: From day of intervention until follow-up (during 1 year)
Global morbidity to 30 days
Morbidity
Measured: From day of intervention until 30 days
Specific morbidity to 30 days
Complications after intervention((cholecystitis, haemorrhage, pancreatitis, angiocholitis, intestinal perforation),
Measured: From day of intervention until 30 days
Overall survival
Overall survival
Measured: From day of intervention until 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start22 Mar 2018
- Primary completion18 Mar 2021
- Study completion11 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonresectable Bile Duct CancerStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BORIES Erwan, MD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679338
- Sponsor's protocol ID
- RFA-BILIAIRE-IPC 2016-003
- Acronym
- RFA-BILIAIRE
- Status last verified
- Jun 2023
- First submitted
- 14 Nov 2017
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Ablation Therapy With Bipolar Radio Frequency for Nonresectable Bile Duct Cancer
- ClinicalTrials.gov ID
- NCT03679338
- Acronym / sponsor ID
- RFA-BILIAIRE / RFA-BILIAIRE-IPC 2016-003
- Conditions
- Nonresectable Bile Duct Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- 18 Mar 2021 (actual)
- Study completion
- 11 Mar 2022 (actual)
- First posted
- 20 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ablation Therapy With Bipolar Radio Frequency | Other | Device: Ablation Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (7 listed)
- Intra-pancreatic mass and/or Wirsung dilation,
- Bile duct cancer,
- Visceral metastasis (extrahepatic),
- Initial metallic prosthesis,
- Woman pregnant or susceptible to the being,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ablation TherapyAblation Therapy With Bipolar Radio frequency | Device | Ablation Therapy With Bipolar Radio Frequency |
Primary outcome
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
5 secondary outcomes
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)
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)
Global morbidity to 30 days
Time frame: From day of intervention until 30 days
Specific morbidity to 30 days
Time frame: From day of intervention until 30 days
Overall survival
Time frame: From day of intervention until 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Institut Paoli-CalmettesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BORIES Erwan, MD principal investigator
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ablation Therapy in people with Nonresectable Bile Duct Cancer, run by Institut Paoli-Calmettes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of success of the use of a treatment based on radiofrequency for all the target stenosis. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023.