Cholangiocarcinoma, Gallbladder Cancer, Pancreatic CancerNCT02646514
Efficacy and Safety of Endobiliary Radiofrequency Ablation by Using a Novel RF Catheter (ELRA®) on Maintaining the Patency of Endobiliary Metal Drainage in Patients With Malignant Biliary Strictures : A Double-arm Comparable Study
A study testing Radiofrequency ablation with stenting and stenting in people with Cholangiocarcinoma, Gallbladder Cancer, Pancreatic Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
Malignant obstructive jaundice is a common complication of advanced stage cholangiocarcinoma, gallbladder cancer, and pancreatic cancer. In biliary stricture by malignancy, biliary drainage with placement of self-expanding metal stent (SEMS) for palliation is the therapy of choice in these patients. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cholangiocarcinoma, Gallbladder Cancer, Pancreatic Cancer
- What is being tested?
- Radiofrequency ablation with stenting and stenting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2015to Sep 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed malignant biliary obstruction or clinically defined malignant biliary obstruction
- older than 19 years old
- Life expectancy > 3 months
- Inoperable case due to advanced stage or comorbidity
- Informed consent
Who cannot join
- Inadequate case for ERCP
- Inadequate coagulation (platelet count < 60,000/µl, PT(INR)>1.5)
- Abnormal biliary tract system due to previous operation
- Failed endoscopic approach to duodenum or biliary tract
- Pregnancy
- No signed informed consent
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital, Yonsei University
Seoul, 120-752
Seungmin Bang, MD, 02-2228-5412, Bang7028@yuhs.ac
Moonjae Chung, MD, 82-10-5058-6865, mjchung@yuhs.ac
About this study
Malignant obstructive jaundice is a common complication of advanced stage cholangiocarcinoma, gallbladder cancer, and pancreatic cancer. In biliary stricture by malignancy, biliary drainage with placement of self-expanding metal stent (SEMS) for palliation is the therapy of choice in these patients. When compared to plastic stents, SEMS present a significantly decreased risk of recurrent biliary obstruction. SEMS are also more cost-effective than plastic stents in patients with a life expectancy of longer than 4 months. However, despite their numerous benefits, SEMS become occluded in up to 50 % of patients in the first 6-8 months.
Radiofrequency ablation (RFA) has been used to treat malignancies of the liver since the early 1990s. Other studies have investigated its role in diseases of the colon and esophagus. More recently, this technique has been recognized for its potential in palliative treatment of malignant biliary strictures. RFA uses a high-frequency alternating current to generate heat and achieve coagulative necrosis when in contact with tissue. Within the bile duct, RFA appears to be safe and may result in decreased benign epithelial hyperplasia and tumor ingrowth. However, RFA along with placement of SEMS has not been well studied. On the other hand, newly developed RFA catheter (ELRA®) showed the feasibility and safety in south korea, recently.
The purpose of this study was to investigate the Efficacy and safety of endobiliary RFA by using a novel RF catheter (ELRA®) on maintaining the patency of endobiliary metal drainage in patients with malignant biliary strictures.
- Being tested
- Radiofrequency ablation with stenting, stenting
- Keywords
- Cholangiocarcinoma, radiofrequency ablation, metal stent
- Medical subject headings
- Cholangiocarcinoma, Gallbladder Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation with stentingDevice
Side viewing endoscope or PTCS scope can be used for all procedures. Cholangiogram is performed to confirm the stricture location, length and diameter. And then, RF catheter (ELRA®) is advanced over a guide wire at the level of the biliary stricture and ablation at 7-10 watts for a time period of 60-120s according to the length is conducted.
After performance of RFA, metal stents are inserted to ensure adequate decompression and bile drainage.
stentingDevice
Metal stents are inserted to ensure adequate decompression and bile drainage. The diameter and stent lengths can be changed according to the lesion.
| Study group | Role | What they receive |
|---|---|---|
| RFA with RF catheter (ELRA®) with stenting | Experimental | Not described Receives: Device: Radiofrequency ablation with stenting |
| stenting | Active comparator | Not described Receives: Device: stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patency of metal stent
Patency of metal stent (From stent insertion date to stent occlusion date or last follow up date if stent is patent)
Measured: 12 months
Secondary outcomes (2)
Overall Survival
Measured: 12 months
Complication rate
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startSep 2015
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cholangiocarcinoma, Gallbladder Cancer, Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646514
- Sponsor's protocol ID
- 1-2015-0053
- Status last verified
- Jan 2019
- First submitted
- 4 Jan 2016
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Sharaiha RZ, Natov N, Glockenberg KS, Widmer J, Gaidhane M, Kahaleh M. Comparison of metal stenting with radiofrequency ablation versus stenting alone for treating malignant biliary strictures: is there an added benefit? Dig Dis Sci. 2014 Dec;59(12):3099-102. doi: 10.1007/s10620-014-3264-6. Epub 2014 Jul 18.
PubMed 25033929Ortner ME, Caca K, Berr F, Liebetruth J, Mansmann U, Huster D, Voderholzer W, Schachschal G, Mossner J, Lochs H. Successful photodynamic therapy for nonresectable cholangiocarcinoma: a randomized prospective study. Gastroenterology. 2003 Nov;125(5):1355-63. doi: 10.1016/j.gastro.2003.07.015.
PubMed 14598251Kang H, Chung MJ, Cho IR, Jo JH, Lee HS, Park JY, Park SW, Song SY, Bang S. Efficacy and safety of palliative endobiliary radiofrequency ablation using a novel temperature-controlled catheter for malignant biliary stricture: a single-center prospective randomized phase II TRIAL. Surg Endosc. 2021 Jan;35(1):63-73. doi: 10.1007/s00464-020-07689-z. Epub 2020 Jun 2.
PubMed 32488654
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Endobiliary Radiofrequency Ablation by Using a Novel RF Catheter (ELRA®) on Maintaining the Patency of Endobiliary Metal Drainage in Patients With Malignant Biliary Strictures : A Double-arm Comparable Study
- ClinicalTrials.gov ID
- NCT02646514
- Acronym / sponsor ID
- 1-2015-0053
- Keywords
- Cholangiocarcinoma, radiofrequency ablation, metal stent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 5 Jan 2016 (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.
Malignant obstructive jaundice is a common complication of advanced stage cholangiocarcinoma, gallbladder cancer, and pancreatic cancer. In biliary stricture by malignancy, biliary drainage with placement of self-expanding metal stent (SEMS) for palliation is the therapy of choice in these patients. When compared to plastic stents, SEMS present a significantly decreased risk of recurrent biliary obstruction. SEMS are also more cost-effective than plastic stents in patients with a life expectancy of longer than 4 months. However, despite their numerous benefits, SEMS become occluded in up to 50 % of patients in the first 6-8 months.
Radiofrequency ablation (RFA) has been used to treat malignancies of the liver since the early 1990s. Other studies have investigated its role in diseases of the colon and esophagus. More recently, this technique has been recognized for its potential in palliative treatment of malignant biliary strictures. RFA uses a high-frequency alternating current to generate heat and achieve coagulative necrosis when in contact with tissue. Within the bile duct, RFA appears to be safe and may result in decreased benign epithelial hyperplasia and tumor ingrowth. However, RFA along with placement of SEMS has not been well studied. On the other hand, newly developed RFA catheter (ELRA®) showed the feasibility and safety in south korea, recently.
The purpose of this study was to investigate the Efficacy and safety of endobiliary RFA by using a novel RF catheter (ELRA®) on maintaining the patency of endobiliary metal drainage in patients with malignant biliary strictures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RFA with RF catheter (ELRA®) with stenting | Experimental | Device: Radiofrequency ablation with stenting |
| stenting | Active comparator | Device: stenting |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pathologically confirmed malignant biliary obstruction or clinically defined malignant biliary obstruction
- older than 19 years old
- Life expectancy > 3 months
- Inoperable case due to advanced stage or comorbidity
- Informed consent
Key exclusion criteria (6 listed)
- Inadequate case for ERCP
- Inadequate coagulation (platelet count < 60,000/µl, PT(INR)>1.5)
- Abnormal biliary tract system due to previous operation
- Failed endoscopic approach to duodenum or biliary tract
- Pregnancy
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 with stentingSide viewing endoscope or PTCS scope can be used for all procedures. Cholangiogram is performed to confirm the stricture location, length and diameter. And then, RF catheter (ELRA®) is advanced over a guide wire at the level of the biliary stricture and ablation at 7-10 watts for a time period of 60-120s according to the length is conducted. After performance of RFA, metal stents are inserted to ensure adequate decompression and bile drainage. | Device | RFA with RF catheter (ELRA®) with stenting |
| stentingMetal stents are inserted to ensure adequate decompression and bile drainage. The diameter and stent lengths can be changed according to the lesion. | Device | stenting |
Primary outcome
Patency of metal stent
Time frame: 12 months
Patency of metal stent (From stent insertion date to stent occlusion date or last follow up date if stent is patent)
2 secondary outcomes
Overall Survival
Time frame: 12 months
Complication rate
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2019.
- Background: PubMed 25033929Sharaiha RZ, Natov N, Glockenberg KS, Widmer J, Gaidhane M, Kahaleh M. Comparison of metal stenting with radiofrequency ablation versus stenting alone for treating malignant biliary strictures: is there an added benefit? Dig Dis Sci. 2014 Dec;59(12):3099-102. doi: 10.1007/s10620-014-3264-6. Epub 2014 Jul 18.
- Background: PubMed 14598251Ortner ME, Caca K, Berr F, Liebetruth J, Mansmann U, Huster D, Voderholzer W, Schachschal G, Mossner J, Lochs H. Successful photodynamic therapy for nonresectable cholangiocarcinoma: a randomized prospective study. Gastroenterology. 2003 Nov;125(5):1355-63. doi: 10.1016/j.gastro.2003.07.015.
- Derived from this study: PubMed 32488654Kang H, Chung MJ, Cho IR, Jo JH, Lee HS, Park JY, Park SW, Song SY, Bang S. Efficacy and safety of palliative endobiliary radiofrequency ablation using a novel temperature-controlled catheter for malignant biliary stricture: a single-center prospective randomized phase II TRIAL. Surg Endosc. 2021 Jan;35(1):63-73. doi: 10.1007/s00464-020-07689-z. Epub 2020 Jun 2.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation with stenting and stenting in people with Cholangiocarcinoma, Gallbladder Cancer, Pancreatic Cancer, run by Yonsei University at 1 site in South Korea.
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 5 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: status not confirmed, as of the sponsor's last update on 28 Jan 2019. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patency of metal stent (time frame: 12 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 NCT02646514, which also lists 3 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 28 Jan 2019.