Hilar CholangiocarcinomaNCT04611100
Efficacy of Intraductal Radiofrequency Ablation in Combination With Metallic Biliary Stenting in Advanced Hilar Cholangiocarcinoma
A study testing ELRA endoluminal radiofrequency ablation electrode (Taewoong, Seoul, Korea) in people with Hilar Cholangiocarcinoma and Biliary Obstruction, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
The study aim to evaluate the efficacy of intraductal radiofrequency ablation for unresetable hilar cholangiocarcinoma in addition to biliary stenting. The patient would be randomized into 1:1 ratio of conventional group who received biliary stenting alone, and RFA group who receive intraductal RFA before biliary… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hilar Cholangiocarcinoma, Biliary Obstruction
- What is being tested?
- ELRA endoluminal radiofrequency ablation electrode (Taewoong, Seoul, Korea)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteThailand
- Study dates
- 1 Apr 2020to 30 Dec 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hilar cholangiocarcinoma diagnosed by imaging or pathology
- Considered unresectable or unfit for surgery
- Presence of obstructive jaundice need endoscopic biliary drainage
Who cannot join
- History of unremovable metallic biliary stent placement
- severe biliary stricture that the instrument was unable to pass through
- unfit for endoscopic under conscious sedation
- loss to follow up and loss contact within 6 months after intervention
Trial locations and contacts
1 site in 1 country.
About this study
The study aim to evaluate the efficacy of intraductal radiofrequency ablation for unresetable hilar cholangiocarcinoma in addition to biliary stenting. The patient would be randomized into 1:1 ratio of conventional group who received biliary stenting alone, and RFA group who receive intraductal RFA before biliary stenting. Immediate complications as well as long term stent patency and patient survival would be studied.
Read the detailed description
Study design: randomized single-blind control trial Study population: patient with unresectable hilar cholangiocarcinoma with obstructive jaundice who need hilar biliary stenting Primary endpoint: Biliary stent patency time Secondary endpoint: Patient survival Intervention
- Recruited patients randomly assigned into 2 groups, conventional and RFA group by sealed enveloped
- All patients receive endoscopic biliary stenting. Those in RFA group receive RFA before biliary stent.
- Monitor for adverse event during hospitalization and during follow up
- Follow up as outpatient in 4-weekly interval with monitoring of serum liver function test as routine
- Conditions
- Hilar Cholangiocarcinoma, Biliary Obstruction
- Being tested
- ELRA endoluminal radiofrequency ablation electrode (Taewoong, Seoul, Korea)
- Keywords
- Hilar cholangiocarcinoma, Biliary obstruction, 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.
ELRA endoluminal radiofrequency ablation electrode (Taewoong, Seoul, Korea)Device
Intraductal radiofrequency ablation using ELRA endoluminal radiofrequency ablation electrode (Taewoong, Seoul, Korea) 10W 2 minutes at the obstructed bile duct before placing uncover self-expandable biliary metal stent
| Study group | Role | What they receive |
|---|---|---|
| Conventional | No intervention | Patient receive endoscopic placement of metallic biliary stent for obstructive jaundice |
| Radiofrequency ablation | Experimental | Patient receive endoscopic intraductal radiofrequency ablation before placement of biliary stent for obstructive jaundice Receives: Device: ELRA endoluminal radiofrequency ablation electrode (Taewoong, Seoul, Korea) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biliary stent patency
The duration between primary intervention and first recurrent increased in serum total bilirubin after intervention up to 6 months after the primary procedure
Measured: up to 6 months
Secondary outcomes (1)
Patient survival
Survival time after primary intervention and documented patient death at 6 months after primary intervention
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start1 Apr 2020
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hilar 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Tanyaporn Chantarojanasiri, MD, Principal investigator, Rajavithi hospital, Bangkok, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611100
- Sponsor's protocol ID
- 111/2562
- Status last verified
- Mar 2020
- First submitted
- 4 Mar 2020
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sripa B, Pairojkul C. Cholangiocarcinoma: lessons from Thailand. Curr Opin Gastroenterol. 2008 May;24(3):349-56. doi: 10.1097/MOG.0b013e3282fbf9b3.
PubMed 18408464Doherty B, Nambudiri VE, Palmer WC. Update on the Diagnosis and Treatment of Cholangiocarcinoma. Curr Gastroenterol Rep. 2017 Jan;19(1):2. doi: 10.1007/s11894-017-0542-4.
PubMed 28110453Heimbach JK, Kulik LM, Finn RS, Sirlin CB, Abecassis MM, Roberts LR, Zhu AX, Murad MH, Marrero JA. AASLD guidelines for the treatment of hepatocellular carcinoma. Hepatology. 2018 Jan;67(1):358-380. doi: 10.1002/hep.29086. No abstract available.
PubMed 28130846Kim JH, Won HJ, Shin YM, Kim PN, Lee SG, Hwang S. Radiofrequency ablation for recurrent intrahepatic cholangiocarcinoma after curative resection. Eur J Radiol. 2011 Dec;80(3):e221-5. doi: 10.1016/j.ejrad.2010.09.019. Epub 2010 Oct 14.
PubMed 20950977Razumilava N, Gores GJ. Cholangiocarcinoma. Lancet. 2014 Jun 21;383(9935):2168-79. doi: 10.1016/S0140-6736(13)61903-0. Epub 2014 Feb 26.
PubMed 24581682
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intraductal Radiofrequency Ablation in Combination With Metallic Biliary Stenting in Advanced Hilar Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT04611100
- Acronym / sponsor ID
- 111/2562
- Conditions
- Hilar Cholangiocarcinoma, Biliary Obstruction
- Keywords
- Hilar cholangiocarcinoma, Biliary obstruction, Radiofrequency ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 2 Nov 2020 (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.
The study aim to evaluate the efficacy of intraductal radiofrequency ablation for unresetable hilar cholangiocarcinoma in addition to biliary stenting. The patient would be randomized into 1:1 ratio of conventional group who received biliary stenting alone, and RFA group who receive intraductal RFA before biliary stenting. Immediate complications as well as long term stent patency and patient survival would be studied.
Detailed description
Study design: randomized single-blind control trial Study population: patient with unresectable hilar cholangiocarcinoma with obstructive jaundice who need hilar biliary stenting Primary endpoint: Biliary stent patency time Secondary endpoint: Patient survival Intervention
- Recruited patients randomly assigned into 2 groups, conventional and RFA group by sealed enveloped
- All patients receive endoscopic biliary stenting. Those in RFA group receive RFA before biliary stent.
- Monitor for adverse event during hospitalization and during follow up
- Follow up as outpatient in 4-weekly interval with monitoring of serum liver function test as routine
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional | No intervention | –Patient receive endoscopic placement of metallic biliary stent for obstructive jaundice |
| Radiofrequency ablation | Experimental | Device: ELRA endoluminal radiofrequency ablation electrode (Taewoong, Seoul, Korea)Patient receive endoscopic intraductal radiofrequency ablation before placement of biliary stent for obstructive jaundice |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hilar cholangiocarcinoma diagnosed by imaging or pathology
- Considered unresectable or unfit for surgery
- Presence of obstructive jaundice need endoscopic biliary drainage
Key exclusion criteria (4 listed)
- History of unremovable metallic biliary stent placement
- severe biliary stricture that the instrument was unable to pass through
- unfit for endoscopic under conscious sedation
- loss to follow up and loss contact within 6 months after intervention
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 |
|---|---|---|
| ELRA endoluminal radiofrequency ablation electrode (Taewoong, Seoul, Korea)Intraductal radiofrequency ablation using ELRA endoluminal radiofrequency ablation electrode (Taewoong, Seoul, Korea) 10W 2 minutes at the obstructed bile duct before placing uncover self-expandable biliary metal stent | Device | Radiofrequency ablation |
Primary outcome
Biliary stent patency
Time frame: up to 6 months
The duration between primary intervention and first recurrent increased in serum total bilirubin after intervention up to 6 months after the primary procedure
1 secondary outcome
Patient survival
Time frame: up to 6 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 Mar 2022.
- Background: PubMed 18408464Sripa B, Pairojkul C. Cholangiocarcinoma: lessons from Thailand. Curr Opin Gastroenterol. 2008 May;24(3):349-56. doi: 10.1097/MOG.0b013e3282fbf9b3.
- Background: PubMed 28110453Doherty B, Nambudiri VE, Palmer WC. Update on the Diagnosis and Treatment of Cholangiocarcinoma. Curr Gastroenterol Rep. 2017 Jan;19(1):2. doi: 10.1007/s11894-017-0542-4.
- Background: PubMed 28130846Heimbach JK, Kulik LM, Finn RS, Sirlin CB, Abecassis MM, Roberts LR, Zhu AX, Murad MH, Marrero JA. AASLD guidelines for the treatment of hepatocellular carcinoma. Hepatology. 2018 Jan;67(1):358-380. doi: 10.1002/hep.29086. No abstract available.
- Background: PubMed 20950977Kim JH, Won HJ, Shin YM, Kim PN, Lee SG, Hwang S. Radiofrequency ablation for recurrent intrahepatic cholangiocarcinoma after curative resection. Eur J Radiol. 2011 Dec;80(3):e221-5. doi: 10.1016/j.ejrad.2010.09.019. Epub 2010 Oct 14.
- Background: PubMed 24581682Razumilava N, Gores GJ. Cholangiocarcinoma. Lancet. 2014 Jun 21;383(9935):2168-79. doi: 10.1016/S0140-6736(13)61903-0. Epub 2014 Feb 26.
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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.
Tanyaporn Chantarojanasiri, MD principal investigator
Rajavithi hospital, Bangkok, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELRA endoluminal radiofrequency ablation electrode (Taewoong, Seoul, Korea) in people with Hilar Cholangiocarcinoma and Biliary Obstruction, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
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 4 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 Mar 2022. 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 Thailand. 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?
Biliary stent patency (time frame: up to 6 months). 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 NCT04611100, which also lists 5 linked publications.
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 Mar 2022.