Endoscopic Biliary RFA of Malignant Bile Duct Obstruction

Cholangiocarcinoma Clinical Trial

Official title:

Endoscopic Biliary Radiofrequency Ablation of Malignant Bile Duct Obstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02582541
• Other study ID #: RFA-CN-1510
• Status: Recruiting
• Phase: N/A
• First received: October 19, 2015
• Last updated: October 19, 2015
• Start date: February 2014
• Est. completion date: November 2018

Study information

• Verified date: October 2015
• Source: The Second Hospital of Nanjing Medical University
• Contact: Lin Miao, MD
• Phone: 086-25-58509932
• Email: miaolinxh[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2018
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Histologically (preferred) or radiologically confirmed distal malignant bile duct tumors

2. Inoperability by staging, comorbidities or patient wishes

Exclusion Criteria:

1. History of bleeding disorder or use of anticoagulation

2. prior cardiac pacemaker placement

3. Presence of serious dysfunction of heart, lung or kidney.

4. Presence of other malignancy

5. Pregnancy

6. Prior SEMS placement

7. Prior Billroth II or roux-en Y reconstruction

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bile Duct Obstruction
• Cholangiocarcinoma
• Cholestasis

Intervention

Procedure:
• SEMS alone
The SEMS (Wallstent, Boston Scientific, USA) would be placed.
• SEMS plus radiofrequency ablation
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.

Locations

Country	Name	City	State
China	Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stent patency rate		6 months	Yes
Secondary	Overall survival		3 years	Yes
Secondary	Number of Participants with Adverse Events		30 days	Yes
Secondary	Change from Baseline in Bile Duct Stricture Diameter		3 years	No