NCT01844245

Endobiliary RFA for Unresectable Malignant Biliary Strictures

Endoscopic Radiofrequency Ablation for Malignant Biliary Strictures Due to Unresectable Cholangiocarcinoma or Ampullary Carcinoma: a Randomised, Controlled, Multicentre Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: Bing Hu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Only a small proportion of patients with cholangiocarcinoma or ampullary carcinoma are suitable for surgical resection. The endoscopic or percutaneous transhepatic biliary drainage is accepted approaches for the relief of jaundice in malignant biliary obstruction. But restoration of bile flow have few improvement of the survival of cancer patient. By using endobiliary radiofrequency energy to destruct the tumorous tissue may delay tumour growth, which might improve the survival of patients. The feasibility and safety of this technique using HabibTM EndoHBP probe has been evident. The aims of this randomised, controlled, multicentre study is to evaluate whether endobiliary radiofrequency ablation(RFA) can improve the median survival of patients with unresectable biliary malignancy.

Detailed description

RFA is well established method for treatment of some solid tumors, like liver cancer, lung cancer, etc. Recently, an endoscopically applicable radiofrequency probe, HabibTM EndoHBP catheter, was approved for clinical use. It uses bipolar electrical energy for tissue coagulation and can be easily applied during endoscopic retrograde cholangiopancreatography (ERCP). Endobiliary radiofrequency can destruct the tumor tissue and has potential benefit for controlling tumour growth. Several cohort studies have been published and the feasibility and safety of such technique has been proved. The aims of this study is to conduct a randomised, controlled, multicentre clinical trial to compare the effect of endobiliary RFA plus biliary stenting with only biliary stenting in patients with unresectable cholangiocarcinoma or ampullary carcinoma. The objectives are * To evaluate whether endobiliary RFA prior to biliary stenting can improve the patients' survival as compared to the only stenting therapy. * To assess the impact of RFA on the stent's patency.

Conditions

• Cholangiocarcinoma
• Ampullary Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Radiofrequency ablation (RFA)	The RFA probe is introduced into bile duct. Bipolar electronic coagulation is performed to the tumorous segment.

Timeline

• Start date: 2013-05-01
• Primary completion: 2017-12-01
• Completion: 2019-07-01
• First posted: 2013-05-01
• Last updated: 2020-10-14

Locations

6 sites across 1 country: China