CholangiocarcinomaNCT02582541
Endoscopic Biliary RFA of Malignant Bile Duct Obstruction
A study testing SEMS alone and SEMS plus radiofrequency ablation in people with Cholangiocarcinoma and Bile Duct Obstruction, run by The Second Hospital of Nanjing Medical University at 1 site in China.
Trial summary
Endoscopic radiofrequency ablation (RFA) is a new palliation therapy for malignant bile duct obstruction. It delivers a high amount of thermal energy to target tissue and may prolong the duration of stent patency. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cholangiocarcinoma, Bile Duct Obstruction
- What is being tested?
- SEMS alone and SEMS plus radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Feb 2014to Nov 2018
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically (preferred) or radiologically confirmed distal malignant bile duct tumors
- Inoperability by staging, comorbidities or patient wishes
Who cannot join
- History of bleeding disorder or use of anticoagulation
- prior cardiac pacemaker placement
- Presence of serious dysfunction of heart, lung or kidney.
- Presence of other malignancy
- Pregnancy
- Prior SEMS placement
- Prior Billroth II or roux-en Y reconstruction
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
Lin Miao, MD, 086-25-58509932, miaolinxh@163.com
About this study
Official title: Endoscopic Biliary Radiofrequency Ablation of Malignant Bile Duct Obstruction
Endoscopic radiofrequency ablation (RFA) is a new palliation therapy for malignant bile duct obstruction. It delivers a high amount of thermal energy to target tissue and may prolong the duration of stent patency. RFA has showed promising results for malignant bile duct obstruction and increasing the duration of stent patency. The aim of our study was to evaluate the feasibility and safety of endoscopic RFA for the treatment of bile duct obstructions, and to compare the efficacy of Endoscopic biliary RFA with the addition of self-expanding metal stents (SEMS) to SEMS alone in a randomized controlled trial.
Read the detailed description
Malignant bile duct obstructions are caused by many diseases arising from primary or metastatic disease in intrahepatic, extrahepatic or hilar locations. To relieve obstructive decompression and jaundice as a result of the obstruction, endoscopic stent placement is usually required. Compared with surgical intervention, stent insertion offers shorter hospitalization, lower overall cost and lower morbidity. Previous studies have shown the superiority of SEMSs over plastic stents for maintaining biliary drainage. However, SEMS can occlude due to epithelial hyperplasia, tumor in-/overgrowth, biofilm deposition and sludge formation. Studies have showed that the median SEMS patency is 120 days. Once bile duct obstruction reoccurs, it may lead to significant morbidity and mortality. Thus, long-term patency of the SEMS remains an unresolved issue.
Recently, endoscopic biliary radiofrequency ablation (RFA) have been used in patients suffering from inoperable malignant bile duct obstruction, and increasing the duration of stent patency. It delivers a high amount of thermal energy to target tissue with curative or palliative intent. The purpose of this study is to record information and evaluate the impact of radiofrequency ablation in improving the management of cholangiocarcinoma or malignant bile duct obstruction, and to compare the effects of SEMS plus RFA to SEMS alone.
- Conditions
- Cholangiocarcinoma, Bile Duct Obstruction
- Being tested
- SEMS alone, SEMS plus radiofrequency ablation
- Medical subject headings
- Cholangiocarcinoma, Cholestasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEMS aloneProcedure or surgery
The SEMS (Wallstent, Boston Scientific, USA) would be placed.
SEMS plus radiofrequency ablationProcedure or surgery
The RFA catheter has an 8 F bipolar probe and two ring electrodes 8 mm apart with the distal electrode 5 mm from the leading edge, providing local coagulative necrosis over a 2.5 cm length. The catheter is compatible with standard side-viewing endoscopes (3.2 mm working channel), and could be passed over 0.035 inch guidewires. Ablation was performed by using an RFA generator (1500 RF generator; RITA Medical Systems, Fremont, Calif) delivering electrical energy at 400 kHz set at 7-10 W for 90-120 seconds. The RFA energy can be delivered repetitively at different tumor sites within one procedure. After the RFA application is completed, SEMS (Wallstent, Boston Scientific, USA) can be deployed.
| Study group | Role | What they receive |
|---|---|---|
| SEMS alone | Active comparator | Endoscopic retrograde cholangiopancreatography (ERCP) was performed under standard operating conditions with a duodenoscope (TJF 260V, Olympus, Tokyo, Japan) to confirm the length of the biliary stricture, diameter, and position. An uncovered self expanding metallic stent (SEMS) (Wallstent, Boston Scientific, USA) would be placed across the biliary stricture. Receives: Procedure: SEMS alone |
| SEMS plus radiofrequency ablation | Experimental | Endoscopic retrograde cholangiopancreatography (ERCP) would be performed under standard operating conditions to confirm the length of the biliary stricture, diameter, and position. The Habib EndoHBP catheter (Emcision, London, United Kingdom) was placed through the biliary stricture under fluoroscopic guidance. The RFA energy can be delivered repetitively at different tumor sites within one procedure, according to the stricture size. After the RFA application is completed, SEMS (Wallstent, Boston Scientific, USA) can be deployed. Receives: Procedure: SEMS plus radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent patency rate
Measured: 6 months
Secondary outcomes (3)
Overall survival
Measured: 3 years
Number of Participants with Adverse Events
Measured: 30 days
Change from Baseline in Bile Duct Stricture Diameter
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startFeb 2014
- Primary completionOct 2015 (estimated)
- Study completionNov 2018 (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 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lin Miao, MD, Principal investigator, Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582541
- Sponsor's protocol ID
- RFA-CN-1510
- Status last verified
- Oct 2015
- First submitted
- 19 Oct 2015
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang F, Li Q, Ge X, Yu H, Nie J, Miao L. Choledochoscopic radiofrequency ablation for congenital choledochal cysts. Endoscopy. 2014;46 Suppl 1 UCTN:E373-4. doi: 10.1055/s-0034-1367604. Epub 2014 Sep 25. No abstract available.
PubMed 25254582Steel AW, Postgate AJ, Khorsandi S, Nicholls J, Jiao L, Vlavianos P, Habib N, Westaby D. Endoscopically applied radiofrequency ablation appears to be safe in the treatment of malignant biliary obstruction. Gastrointest Endosc. 2011 Jan;73(1):149-53. doi: 10.1016/j.gie.2010.09.031.
PubMed 21184881Wadsworth CA, Westaby D, Khan SA. Endoscopic radiofrequency ablation for cholangiocarcinoma. Curr Opin Gastroenterol. 2013 May;29(3):305-11. doi: 10.1097/MOG.0b013e32835faacc.
PubMed 23449026
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Biliary Radiofrequency Ablation of Malignant Bile Duct Obstruction
- ClinicalTrials.gov ID
- NCT02582541
- Acronym / sponsor ID
- RFA-CN-1510
- Conditions
- Cholangiocarcinoma, Bile Duct Obstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Second Hospital of Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 21 Oct 2015 (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.
Endoscopic radiofrequency ablation (RFA) is a new palliation therapy for malignant bile duct obstruction. It delivers a high amount of thermal energy to target tissue and may prolong the duration of stent patency. RFA has showed promising results for malignant bile duct obstruction and increasing the duration of stent patency. The aim of our study was to evaluate the feasibility and safety of endoscopic RFA for the treatment of bile duct obstructions, and to compare the efficacy of Endoscopic biliary RFA with the addition of self-expanding metal stents (SEMS) to SEMS alone in a randomized controlled trial.
Detailed description
Malignant bile duct obstructions are caused by many diseases arising from primary or metastatic disease in intrahepatic, extrahepatic or hilar locations. To relieve obstructive decompression and jaundice as a result of the obstruction, endoscopic stent placement is usually required. Compared with surgical intervention, stent insertion offers shorter hospitalization, lower overall cost and lower morbidity. Previous studies have shown the superiority of SEMSs over plastic stents for maintaining biliary drainage. However, SEMS can occlude due to epithelial hyperplasia, tumor in-/overgrowth, biofilm deposition and sludge formation. Studies have showed that the median SEMS patency is 120 days. Once bile duct obstruction reoccurs, it may lead to significant morbidity and mortality. Thus, long-term patency of the SEMS remains an unresolved issue.
Recently, endoscopic biliary radiofrequency ablation (RFA) have been used in patients suffering from inoperable malignant bile duct obstruction, and increasing the duration of stent patency. It delivers a high amount of thermal energy to target tissue with curative or palliative intent. The purpose of this study is to record information and evaluate the impact of radiofrequency ablation in improving the management of cholangiocarcinoma or malignant bile duct obstruction, and to compare the effects of SEMS plus RFA to SEMS alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SEMS alone | Active comparator | Procedure: SEMS aloneEndoscopic retrograde cholangiopancreatography (ERCP) was performed under standard operating conditions with a duodenoscope (TJF 260V, Olympus, Tokyo, Japan) to confirm the length of the biliary stricture, diameter, and position. An uncovered self expanding metallic stent (SEMS) (Wallstent, Boston Scientific, USA) would be placed across the biliary stricture. |
| SEMS plus radiofrequency ablation | Experimental | Procedure: SEMS plus radiofrequency ablationEndoscopic retrograde cholangiopancreatography (ERCP) would be performed under standard operating conditions to confirm the length of the biliary stricture, diameter, and position. The Habib EndoHBP catheter (Emcision, London, United Kingdom) was placed through the biliary stricture under fluoroscopic guidance. The RFA energy can be delivered repetitively at different tumor sites within one procedure, according to the stricture size. After the RFA application is completed, SEMS (Wallstent, Boston Scientific, USA) can be deployed. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologically (preferred) or radiologically confirmed distal malignant bile duct tumors
- Inoperability by staging, comorbidities or patient wishes
Key exclusion criteria (7 listed)
- History of bleeding disorder or use of anticoagulation
- prior cardiac pacemaker placement
- Presence of serious dysfunction of heart, lung or kidney.
- Presence of other malignancy
- 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 |
|---|---|---|
| SEMS aloneThe SEMS (Wallstent, Boston Scientific, USA) would be placed. | Procedure or surgery | SEMS alone |
| SEMS plus radiofrequency ablationThe RFA catheter has an 8 F bipolar probe and two ring electrodes 8 mm apart with the distal electrode 5 mm from the leading edge, providing local coagulative necrosis over a 2.5 cm length. The catheter is compatible with standard side-viewing endoscopes (3.2 mm working channel), and could be passed over 0.035 inch guidewires. Ablation was performed by using an RFA generator (1500 RF generator; RITA Medical Systems, Fremont, Calif) delivering electrical energy at 400 kHz set at 7-10 W for 90-120 seconds. The RFA energy can be delivered repetitively at different tumor sites within one procedure. After the RFA application is completed, SEMS (Wallstent, Boston Scientific, USA) can be deployed. | Procedure or surgery | SEMS plus radiofrequency ablation |
Primary outcome
Stent patency rate
Time frame: 6 months
3 secondary outcomes
Overall survival
Time frame: 3 years
Number of Participants with Adverse Events
Time frame: 30 days
Change from Baseline in Bile Duct Stricture Diameter
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
- Background: PubMed 25254582Wang F, Li Q, Ge X, Yu H, Nie J, Miao L. Choledochoscopic radiofrequency ablation for congenital choledochal cysts. Endoscopy. 2014;46 Suppl 1 UCTN:E373-4. doi: 10.1055/s-0034-1367604. Epub 2014 Sep 25. No abstract available.
- Background: PubMed 21184881Steel AW, Postgate AJ, Khorsandi S, Nicholls J, Jiao L, Vlavianos P, Habib N, Westaby D. Endoscopically applied radiofrequency ablation appears to be safe in the treatment of malignant biliary obstruction. Gastrointest Endosc. 2011 Jan;73(1):149-53. doi: 10.1016/j.gie.2010.09.031.
- Background: PubMed 23449026Wadsworth CA, Westaby D, Khan SA. Endoscopic radiofrequency ablation for cholangiocarcinoma. Curr Opin Gastroenterol. 2013 May;29(3):305-11. doi: 10.1097/MOG.0b013e32835faacc.
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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.
Lin Miao, MD principal investigator
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SEMS alone and SEMS plus radiofrequency ablation in people with Cholangiocarcinoma and Bile Duct Obstruction, run by The Second Hospital of Nanjing Medical University at 1 site 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 2 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: status not confirmed, as of the sponsor's last update on 21 Oct 2015. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Miao, MD (086-25-58509932, miaolinxh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stent patency rate (time frame: 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 NCT02582541, 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 21 Oct 2015.