CholangiocarcinomaNCT01844245
Endobiliary RFA for Unresectable Malignant Biliary Strictures
A study testing Radiofrequency ablation (RFA) in people with Cholangiocarcinoma and Ampullary Carcinoma, run by Bing Hu at 6 sites in China.
Trial summary
Only a small proportion of patients with cholangiocarcinoma or ampullary carcinoma are suitable for surgical resection. The endoscopic or percutaneous transhepatic biliary drainage is accepted approaches for the relief of jaundice in malignant biliary obstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma, Ampullary Carcinoma
- What is being tested?
- Radiofrequency ablation (RFA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 6 sitesChina
- Study dates
- May 2013to Jul 2019
- 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
- Either gender greater than or equal to 18 years of age.
- Cholangiocarcinoma or ampullary cancer unsuitable for surgical resection by staging, comorbidities or patient wishes. Criteria of unresectability being based on 1) metastatic disease or 2) locally advanced.
- Biliary obstruction, Bilirubin > 40umol/L at diagnosis
- Subjects capable of giving informed consent
- Life expectancy of at least 3 months
- Histologically (preferred) or radiologically confirmed cholangiocarcinoma or ampullary cancer
Who cannot join
- Cardiac Pacemaker
- Patient unstable for endoscopy
- Inability to give informed consent
- Coagulopathy (INR > 2.0 or PTT > 100 sec or platelet count < 50,000)
- Performance status ECOG ≥3 (confined to bed / chair > 50% waking hours)
- Active suppurative cholangitis
Show all 16Show fewer
- Complex stenoses will not be eligible for the trial
- Patients without access to duodenum or ampulla are not candidates for ERCP and stenting
- Malignant ascites
- Presence of main portal vein thrombosis
- Prior stents placement
- Prior Billroth II or roux-en Y reconstruction
- Inability to insert a guide wire across the malignant stricture
- Pregnancy
- Presence of other malignancy
- Life expectancy < 3months
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Beijing Friendship Hospital Affiliated to Capital University of Medical Sciences
Beijing, Beijing Municipality, 100050
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310006
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai Municipality, 200438
The General Hospital of Shenyang Military Region
Shenyang, Liaoning, 110015
Xijing Hospital of the Forth Military Medical University
Xi’an, Shanxi, 710032
About this study
Official title: Endoscopic Radiofrequency Ablation for Malignant Biliary Strictures Due to Unresectable Cholangiocarcinoma or Ampullary Carcinoma: a Randomised, Controlled, Multicentre Clinical Trial
Only a small proportion of patients with cholangiocarcinoma or ampullary carcinoma are suitable for surgical resection. The endoscopic or percutaneous transhepatic biliary drainage is accepted approaches for the relief of jaundice in malignant biliary obstruction. But restoration of bile flow have few improvement of the survival of cancer patient. By using endobiliary radiofrequency energy to destruct the tumorous tissue may delay tumour growth, which might improve the survival of patients. The feasibility and safety of this technique using HabibTM EndoHBP probe has been evident. The aims of this randomised, controlled, multicentre study is to evaluate whether endobiliary radiofrequency ablation(RFA) can improve the median survival of patients with unresectable biliary malignancy.
Read the detailed description
RFA is well established method for treatment of some solid tumors, like liver cancer, lung cancer, etc. Recently, an endoscopically applicable radiofrequency probe, HabibTM EndoHBP catheter, was approved for clinical use. It uses bipolar electrical energy for tissue coagulation and can be easily applied during endoscopic retrograde cholangiopancreatography (ERCP). Endobiliary radiofrequency can destruct the tumor tissue and has potential benefit for controlling tumour growth. Several cohort studies have been published and the feasibility and safety of such technique has been proved.
The aims of this study is to conduct a randomised, controlled, multicentre clinical trial to compare the effect of endobiliary RFA plus biliary stenting with only biliary stenting in patients with unresectable cholangiocarcinoma or ampullary carcinoma.
The objectives are
- To evaluate whether endobiliary RFA prior to biliary stenting can improve the patients' survival as compared to the only stenting therapy.
- To assess the impact of RFA on the stent's patency.
- Conditions
- Cholangiocarcinoma, Ampullary Carcinoma
- Being tested
- Radiofrequency ablation (RFA)
- Keywords
- Cholangiocarcinoma, Ampullary carcinoma, Endoscopic retrograde cholangiopancreatography, Radiofrequency ablation
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation (RFA)Procedure or surgery
Also called Endobiliary RFA
The RFA probe is introduced into bile duct. Bipolar electronic coagulation is performed to the tumorous segment.
| Study group | Role | What they receive |
|---|---|---|
| Endobiliary RFA group | Experimental | 1. Endoscopic retrograde cholangiopancreatography (ERCP) would be performed under standard operating conditions to confirm the biliary malignancy. Subjects will receive endobiliary radiofrequency ablation (Endobiliary RFA) followed by plastic stent(s) placement.
2. Three months later, subjects will receive the second RFA therapy followed by biliary stents (plastic or SEMS) placement.
3. During follow-up, if stent occlusion occurs, the patient will undergo endoscopic re-intervention for stent exchange without endobiliary RFA Receives: Procedure: Radiofrequency ablation (RFA) |
| Control group | No intervention | 1. Endoscopic retrograde cholangiopancreatography (ERCP) would be performed under standard operating conditions to confirm the biliary malignancy. Subjects will receive plastic biliary stent(s) placement only. 2. Three months later, subjects will receive the second endoscopic intervention for stents (plastic or SEMS) exchange. 3. During follow-up, if stent occlusion occurs, the patient will undergo endoscopic re-intervention for stent exchange without endobiliary RFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 2 years
Secondary outcomes (3)
Patency of stents
Measured: 6 months
Unscheduled readmission rates
Measured: 6 months
Serious adverse events
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2017
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bing Hu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bing Hu, Eastern Hepatobiliary Surgery Hospital
- Investigators
- Bing Hu, MD, PhD, Principal investigator, Eastern Hepatobiliary Surgery Hospital, The Second Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01844245
- Sponsor's protocol ID
- EHBH B-RFA 2013-001
- Status last verified
- Oct 2020
- First submitted
- 28 Apr 2013
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Gao DJ, Yang JF, Ma SR, Wu J, Wang TT, Jin HB, Xia MX, Zhang YC, Shen HZ, Ye X, Zhang XF, Hu B. Endoscopic radiofrequency ablation plus plastic stent placement versus stent placement alone for unresectable extrahepatic biliary cancer: a multicenter randomized controlled trial. Gastrointest Endosc. 2021 Jul;94(1):91-100.e2. doi: 10.1016/j.gie.2020.12.016. Epub 2020 Dec 24.
PubMed 33359435
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Radiofrequency Ablation for Malignant Biliary Strictures Due to Unresectable Cholangiocarcinoma or Ampullary Carcinoma: a Randomised, Controlled, Multicentre Clinical Trial
- ClinicalTrials.gov ID
- NCT01844245
- Acronym / sponsor ID
- EHBH B-RFA 2013-001
- Conditions
- Cholangiocarcinoma, Ampullary Carcinoma
- Keywords
- Cholangiocarcinoma, Ampullary carcinoma, Endoscopic retrograde cholangiopancreatography, Radiofrequency ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Bing HuUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 1 May 2013 (estimated)
- 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.
Only a small proportion of patients with cholangiocarcinoma or ampullary carcinoma are suitable for surgical resection. The endoscopic or percutaneous transhepatic biliary drainage is accepted approaches for the relief of jaundice in malignant biliary obstruction. But restoration of bile flow have few improvement of the survival of cancer patient. By using endobiliary radiofrequency energy to destruct the tumorous tissue may delay tumour growth, which might improve the survival of patients. The feasibility and safety of this technique using HabibTM EndoHBP probe has been evident. The aims of this randomised, controlled, multicentre study is to evaluate whether endobiliary radiofrequency ablation(RFA) can improve the median survival of patients with unresectable biliary malignancy.
Detailed description
RFA is well established method for treatment of some solid tumors, like liver cancer, lung cancer, etc. Recently, an endoscopically applicable radiofrequency probe, HabibTM EndoHBP catheter, was approved for clinical use. It uses bipolar electrical energy for tissue coagulation and can be easily applied during endoscopic retrograde cholangiopancreatography (ERCP). Endobiliary radiofrequency can destruct the tumor tissue and has potential benefit for controlling tumour growth. Several cohort studies have been published and the feasibility and safety of such technique has been proved.
The aims of this study is to conduct a randomised, controlled, multicentre clinical trial to compare the effect of endobiliary RFA plus biliary stenting with only biliary stenting in patients with unresectable cholangiocarcinoma or ampullary carcinoma.
The objectives are
- To evaluate whether endobiliary RFA prior to biliary stenting can improve the patients' survival as compared to the only stenting therapy.
- To assess the impact of RFA on the stent's patency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endobiliary RFA group | Experimental | Procedure: Radiofrequency ablation (RFA)1. Endoscopic retrograde cholangiopancreatography (ERCP) would be performed under standard operating conditions to confirm the biliary malignancy. Subjects will receive endobiliary radiofrequency ablation (Endobiliary RFA) followed by plastic stent(s) placement. 2. Three months later, subjects will receive the second RFA therapy followed by biliary stents (plastic or SEMS) placement. 3. During follow-up, if stent occlusion occurs, the patient will undergo endoscopic re-intervention for stent exchange without endobiliary RFA |
| Control group | No intervention | –1. Endoscopic retrograde cholangiopancreatography (ERCP) would be performed under standard operating conditions to confirm the biliary malignancy. Subjects will receive plastic biliary stent(s) placement only. 2. Three months later, subjects will receive the second endoscopic intervention for stents (plastic or SEMS) exchange. 3. During follow-up, if stent occlusion occurs, the patient will undergo endoscopic re-intervention for stent exchange without endobiliary RFA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Either gender greater than or equal to 18 years of age.
- Cholangiocarcinoma or ampullary cancer unsuitable for surgical resection by staging, comorbidities or patient wishes. Criteria of unresectability being based on 1) metastatic disease or 2) locally advanced.
- Biliary obstruction, Bilirubin > 40umol/L at diagnosis
- Subjects capable of giving informed consent
- Life expectancy of at least 3 months
Key exclusion criteria (16 listed)
- Cardiac Pacemaker
- Patient unstable for endoscopy
- Inability to give informed consent
- Coagulopathy (INR > 2.0 or PTT > 100 sec or platelet count < 50,000)
- Performance status ECOG ≥3 (confined to bed / chair > 50% waking hours)
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 |
|---|---|---|
| Radiofrequency ablation (RFA)Also: Endobiliary RFAThe RFA probe is introduced into bile duct. Bipolar electronic coagulation is performed to the tumorous segment. | Procedure or surgery | Endobiliary RFA group |
Primary outcome
Overall survival
Time frame: 2 years
3 secondary outcomes
Patency of stents
Time frame: 6 months
Unscheduled readmission rates
Time frame: 6 months
Serious adverse events
Time frame: 30 days
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 14 Oct 2020.
- Derived from this study: PubMed 33359435Gao DJ, Yang JF, Ma SR, Wu J, Wang TT, Jin HB, Xia MX, Zhang YC, Shen HZ, Ye X, Zhang XF, Hu B. Endoscopic radiofrequency ablation plus plastic stent placement versus stent placement alone for unresectable extrahepatic biliary cancer: a multicenter randomized controlled trial. Gastrointest Endosc. 2021 Jul;94(1):91-100.e2. doi: 10.1016/j.gie.2020.12.016. Epub 2020 Dec 24.
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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.
Bing Hu, MD, PhD principal investigator
Eastern Hepatobiliary Surgery Hospital, The Second Military Medical University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation (RFA) in people with Cholangiocarcinoma and Ampullary Carcinoma, run by Bing Hu at 6 sites in China.
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 16 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 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. 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?
Overall survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01844245, which also lists 1 linked publication.
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 14 Oct 2020.