- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02582541
Endoscopic Biliary RFA of Malignant Bile Duct Obstruction
Endoscopic Biliary Radiofrequency Ablation of Malignant Bile Duct Obstruction
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Jiangsu
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Nanjing, Jiangsu, China, 210011
- Recruiting
- Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically (preferred) or radiologically confirmed distal malignant bile duct tumors
- Inoperability by staging, comorbidities or patient wishes
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: SEMS alone
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.
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The SEMS (Wallstent, Boston Scientific, USA) would be placed.
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Experimental: SEMS plus radiofrequency ablation
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Stent patency rate
Time Frame: 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Overall survival
Time Frame: 3 years
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3 years
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Number of Participants with Adverse Events
Time Frame: 30 days
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30 days
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Change from Baseline in Bile Duct Stricture Diameter
Time Frame: 3 years
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3 years
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Collaborators and Investigators
Publications and helpful links
General Publications
- Steel 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.
- 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.
- Wadsworth CA, Westaby D, Khan SA. Endoscopic radiofrequency ablation for cholangiocarcinoma. Curr Opin Gastroenterol. 2013 May;29(3):305-11. doi: 10.1097/MOG.0b013e32835faacc.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RFA-CN-1510
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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