Perihilar CholangiocarcinomaCOMBO-RFANCT05563870
Endoscopy and Radiology-guided Ablation for Inoperable Cholangiocarcinoma
A study testing Endoluminal radiofrequency ablation and Endoscopic biliary stenting in people with Perihilar Cholangiocarcinoma, run by Clinical Hospital Colentina at 1 site in Romania.
Trial summary
This prospective clinical trial aims to assess the feasibility, efficacy, and safety of a personalized radiofrequency ablation protocol coupled with complete biliary drainage for patients presenting with inoperable perihilar cholangiocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perihilar Cholangiocarcinoma
- What is being tested?
- Endoluminal radiofrequency ablation and Endoscopic biliary stenting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteRomania
- Study dates
- 1 Aug 2022to 20 Jul 2026
- Phase
- Interventional
- 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
- perihilar cholangiocarcinoma
- locally advanced disease (unresectable)
- M1 (limted to 1 site)
Who cannot join
- refusal to sogn the ICF
- poor performance status (ECOG >2)
- surgically altered anatomy (i.e Bilroth II or Roux-en-Y interventions)
- significant comorbidities
- ASA score >3
- life expectancy <3 months
Trial locations and contacts
1 site in 1 country.
Romania1 site
Gastroenterology Department, Colentina Hospital
Bucharest, 020125
About this study
Official title: A Combined Endoscopy and Radiology-guided Radiofrequency Ablation Therapy Protocol for Inoperable Perihilar Cholangiocarcinoma
This prospective clinical trial aims to assess the feasibility, efficacy, and safety of a personalized radiofrequency ablation protocol coupled with complete biliary drainage for patients presenting with inoperable perihilar cholangiocarcinoma.
Read the detailed description
This clinical trial proposes a personalized treatment approach to inoperable perihilar cholangiocarcinoma consisting of endoluminal ablative therapy via radiofrequency ablation followed by endoscopic biliary drainage.
Patients presenting with jaundice / biliary obstruction caused by inoperable perihilar cholangiocarcinoma as assessed during multidisciplinary case discussion will be invited to enroll in this trial.
Patients will be randomized in a 1:1 fashion to receive biliary plastic stenting (control arm) or biliary plastic stenting + radiofrequency ablation via endoscopic approach. In cases where ERCP fails to achieve adequate biliary drainage, stenting and/or drainage will be attempted via percutaneous approach.
Additional systemic chemotherapy will be offered to all eligible patients according to the local standard of care.
Patients will be followed up with a clinical visit at 2 weeks and stent exchange (+ additional RFA treatment in the control arm) will be offered at 8-12 weeks interval until disease progression, clinical deterioration precluding ERCP or death.
The main study objectives are:
- To assess the technical feasibility of implementing the proposed therapeutic protocol involving a combined endoscopic-radiologic approach to drainage and ablation
- To evaluate the efficacy of radiofrequency ablation in local disease control
- To evaluate whether complete drainage and radiofrequency ablation have a cumulative benefit in patients with inoperable perihilar cholangiocarcinoma
- To evaluate the safety of our proposed therapeutic protocol combining interventional endoscopy with radiology
- Conditions
- Perihilar Cholangiocarcinoma
- Being tested
- Endoluminal radiofrequency ablation, Endoscopic biliary stenting
- Keywords
- perihilar cholangiocarcinoma, ERCP, Radiofrequency ablation
- Medical subject headings
- Klatskin Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoluminal radiofrequency ablationProcedure or surgery
Endoluminal Radiofrequency ablation (RFA) of the entire stricture length will be performed using the Habib probe. A current of 7W will be delivered for 90s intervals at a time. If multiple ablation sessions are needed in order to ablate the entire stricture lenght, there will be an overlap of ablated areas in order to ensure proper stricture treatment. Dilation of the stricture prior to RFA delivery will be performed if required. After RFA treatment, biliary drainage of all hepatic territories will be ensured.
Endoscopic biliary stentingProcedure or surgery
Endoscopic biliary stenting will be performed via ERCP using multiple plastic stents, in order to ensure propper drainage of all accessed hepatic territories.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Drainage Arm | Active comparator | Patients randomized to this arm will undergo biliary stenting only Receives: Procedure: Endoscopic biliary stenting |
| COMBO-RFA Arm | Experimental | Patients randomized to this arm will undergo same-session endoluminal radiofrequency ablation followed by biliary stenting Receives: Procedure: Endoluminal radiofrequency ablation; Procedure: Endoscopic biliary stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success of ERCP procedure
Ability to correctly apply radiofrequency ablation and place stents in all the biliary ducts accessed on ERCP
Measured: 2 months
Tumor response
To evaluate the efficacy of radiofrequency ablation in local disease control by assessing tumor response according to RECIST criteria at 6 months follow-up
Measured: 6 months
Secondary outcomes (3)
Rate of procedure-related adverse events
To evaluate the safety profile of the procedure by assessing the rate of procedure-related adverse events according to the ASGE lexicon (cholangitis, bleeding, perforation, pancreatitis) after endoscopic treatment
Measured: 12 months
Overall survival
To assess patient survival rates at 12 months follow-up
Measured: 12 months
Tumor microenvironment alterations
To evaluate the expression of programmed death (PD)-1 / PD- ligand 1 markers on biopsy samples of tumor tissue obtained at the index and follow-up ERCP procedure
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start1 Aug 2022
- Primary completion20 Jul 2026
- Study completion20 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perihilar CholangiocarcinomaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Colentina
- Sponsor type
- University, hospital or other
- Collaborators
- Carol Davila University of Medicine and Pharmacy, Universitatea din Bucuresti, Asociatia pentru cercetare si educatie in gastroenterologie (ACEG)
- Responsible party
- Principal investigator, dr. Theodor Alexandru Voiosu, Clinical Hospital Colentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563870
- Sponsor's protocol ID
- COMBO-RFA
- Acronym
- COMBO-RFA
- Status last verified
- Jul 2026
- First submitted
- 20 Sep 2022
- Last updated
- 29 Jul 2026
- 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 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combined Endoscopy and Radiology-guided Radiofrequency Ablation Therapy Protocol for Inoperable Perihilar Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT05563870
- Acronym / sponsor ID
- COMBO-RFA / COMBO-RFA
- Conditions
- Perihilar Cholangiocarcinoma
- Keywords
- perihilar cholangiocarcinoma, ERCP, Radiofrequency ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Clinical Hospital ColentinaUniversity, hospital or other
- Collaborators
- Carol Davila University of Medicine and Pharmacy, Universitatea din Bucuresti, Asociatia pentru cercetare si educatie in gastroenterologie (ACEG)
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 20 Jul 2026 (actual)
- Study completion
- 20 Jul 2026 (actual)
- First posted
- 3 Oct 2022 (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.
This prospective clinical trial aims to assess the feasibility, efficacy, and safety of a personalized radiofrequency ablation protocol coupled with complete biliary drainage for patients presenting with inoperable perihilar cholangiocarcinoma.
Detailed description
This clinical trial proposes a personalized treatment approach to inoperable perihilar cholangiocarcinoma consisting of endoluminal ablative therapy via radiofrequency ablation followed by endoscopic biliary drainage.
Patients presenting with jaundice / biliary obstruction caused by inoperable perihilar cholangiocarcinoma as assessed during multidisciplinary case discussion will be invited to enroll in this trial.
Patients will be randomized in a 1:1 fashion to receive biliary plastic stenting (control arm) or biliary plastic stenting + radiofrequency ablation via endoscopic approach. In cases where ERCP fails to achieve adequate biliary drainage, stenting and/or drainage will be attempted via percutaneous approach.
Additional systemic chemotherapy will be offered to all eligible patients according to the local standard of care.
Patients will be followed up with a clinical visit at 2 weeks and stent exchange (+ additional RFA treatment in the control arm) will be offered at 8-12 weeks interval until disease progression, clinical deterioration precluding ERCP or death.
The main study objectives are:
- To assess the technical feasibility of implementing the proposed therapeutic protocol involving a combined endoscopic-radiologic approach to drainage and ablation
- To evaluate the efficacy of radiofrequency ablation in local disease control
- To evaluate whether complete drainage and radiofrequency ablation have a cumulative benefit in patients with inoperable perihilar cholangiocarcinoma
- To evaluate the safety of our proposed therapeutic protocol combining interventional endoscopy with radiology
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Drainage Arm | Active comparator | Procedure: Endoscopic biliary stentingPatients randomized to this arm will undergo biliary stenting only |
| COMBO-RFA Arm | Experimental | Procedure: Endoluminal radiofrequency ablation, Procedure: Endoscopic biliary stentingPatients randomized to this arm will undergo same-session endoluminal radiofrequency ablation followed by biliary stenting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- perihilar cholangiocarcinoma
- locally advanced disease (unresectable)
- M1 (limted to 1 site)
Key exclusion criteria (6 listed)
- refusal to sogn the ICF
- poor performance status (ECOG >2)
- surgically altered anatomy (i.e Bilroth II or Roux-en-Y interventions)
- significant comorbidities
- ASA score >3
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 |
|---|---|---|
| Endoluminal radiofrequency ablationEndoluminal Radiofrequency ablation (RFA) of the entire stricture length will be performed using the Habib probe. A current of 7W will be delivered for 90s intervals at a time. If multiple ablation sessions are needed in order to ablate the entire stricture lenght, there will be an overlap of ablated areas in order to ensure proper stricture treatment. Dilation of the stricture prior to RFA delivery will be performed if required. After RFA treatment, biliary drainage of all hepatic territories will be ensured. | Procedure or surgery | COMBO-RFA Arm |
| Endoscopic biliary stentingEndoscopic biliary stenting will be performed via ERCP using multiple plastic stents, in order to ensure propper drainage of all accessed hepatic territories. | Procedure or surgery | COMBO-RFA Arm, Endoscopic Drainage Arm |
Primary outcome
Technical success of ERCP procedure
Time frame: 2 months
Ability to correctly apply radiofrequency ablation and place stents in all the biliary ducts accessed on ERCP
Tumor response
Time frame: 6 months
To evaluate the efficacy of radiofrequency ablation in local disease control by assessing tumor response according to RECIST criteria at 6 months follow-up
3 secondary outcomes
Rate of procedure-related adverse events
Time frame: 12 months
Overall survival
Time frame: 12 months
Tumor microenvironment alterations
Time frame: 2 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 29 Jul 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoluminal radiofrequency ablation and Endoscopic biliary stenting in people with Perihilar Cholangiocarcinoma, run by Clinical Hospital Colentina at 1 site in Romania.
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 3 inclusion and 6 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 29 Jul 2026. 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 Romania. 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.
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?
Technical success of ERCP procedure (time frame: 2 months). The study lists 2 primary outcomes in all. 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 29 Jul 2026.