Endoscopic Biliary RFA of Malignant Bile Duct Obstruction
Endoscopic Biliary Radiofrequency Ablation of Malignant Bile Duct Obstruction
1 other identifier
interventional
100
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 19, 2015
CompletedFirst Posted
Study publicly available on registry
October 21, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedOctober 21, 2015
October 1, 2015
1.7 years
October 19, 2015
October 19, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Stent patency rate
6 months
Secondary Outcomes (3)
Overall survival
3 years
Number of Participants with Adverse Events
30 days
Change from Baseline in Bile Duct Stricture Diameter
3 years
Study Arms (2)
SEMS alone
ACTIVE COMPARATOREndoscopic 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
EXPERIMENTALEndoscopic 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Histologically (preferred) or radiologically confirmed distal malignant bile duct tumors
- Inoperability by staging, comorbidities or patient wishes
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011, China
Related Publications (3)
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.
PMID: 25254582BACKGROUNDSteel 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.
PMID: 21184881BACKGROUNDWadsworth CA, Westaby D, Khan SA. Endoscopic radiofrequency ablation for cholangiocarcinoma. Curr Opin Gastroenterol. 2013 May;29(3):305-11. doi: 10.1097/MOG.0b013e32835faacc.
PMID: 23449026BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lin Miao, MD
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2015
First Posted
October 21, 2015
Study Start
February 1, 2014
Primary Completion
October 1, 2015
Study Completion
November 1, 2018
Last Updated
October 21, 2015
Record last verified: 2015-10