Endobiliary RFA for Unresectable Malignant Biliary Strictures
- Conditions
- CholangiocarcinomaAmpullary Carcinoma
- Interventions
- Procedure: Radiofrequency ablation (RFA)
- Registration Number
- NCT01844245
- Lead Sponsor
- Bing Hu
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 174
- Either gender greater than or equal to 18 years of age.
- Cholangiocarcinoma or ampullary cancer unsuitable for surgical resection by staging, comorbidities or patient wishes. Criteria of unresectability being based on 1) metastatic disease or 2) locally advanced.
- Biliary obstruction, Bilirubin > 40umol/L at diagnosis
- Subjects capable of giving informed consent
- Life expectancy of at least 3 months
- Histologically (preferred) or radiologically confirmed cholangiocarcinoma or ampullary cancer
- Cardiac Pacemaker
- Patient unstable for endoscopy
- Inability to give informed consent
- Coagulopathy (INR > 2.0 or PTT > 100 sec or platelet count < 50,000)
- Performance status ECOG β₯3 (confined to bed / chair > 50% waking hours)
- Active suppurative cholangitis
- Complex stenoses will not be eligible for the trial
- Patients without access to duodenum or ampulla are not candidates for ERCP and stenting
- Malignant ascites
- Presence of main portal vein thrombosis
- Prior stents placement
- Prior Billroth II or roux-en Y reconstruction
- Inability to insert a guide wire across the malignant stricture
- Pregnancy
- Presence of other malignancy
- Life expectancy < 3months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Endobiliary RFA group Radiofrequency ablation (RFA) 1. Endoscopic retrograde cholangiopancreatography (ERCP) would be performed under standard operating conditions to confirm the biliary malignancy. Subjects will receive endobiliary radiofrequency ablation (Endobiliary RFA) followed by plastic stent(s) placement. 2. Three months later, subjects will receive the second RFA therapy followed by biliary stents (plastic or SEMS) placement. 3. During follow-up, if stent occlusion occurs, the patient will undergo endoscopic re-intervention for stent exchange without endobiliary RFA
- Primary Outcome Measures
Name Time Method Overall survival 2 years
- Secondary Outcome Measures
Name Time Method Serious adverse events 30 days Patency of stents 6 months Unscheduled readmission rates 6 months
Trial Locations
- Locations (6)
Xijing Hospital of the Forth Military Medical University
π¨π³Xi'an, Shanxi, China
The General Hospital of Shenyang Military Region
π¨π³Shenyang, Liaoning, China
Hangzhou First People's Hospital
π¨π³Hangzhou, Zhejiang, China
Beijing Friendship Hospital Affiliated to Capital University of Medical Sciences
π¨π³Beijing, Beijing, China
The First Affiliated Hospital of Guangxi Medical University
π¨π³Nanning, Guangxi, China
Eastern Hepatobiliary Surgery Hospital
π¨π³Shanghai, Shanghai, China