Endobiliary RFA for Unresectable Malignant Biliary Strictures

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cholangiocarcinoma, Ampullary Carcinoma

Intervention / Treatment
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* Procedure: Radiofrequency ablation (RFA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 ≥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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endobiliary RFA group<br>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. Three months later, subjects will receive the second RFA therapy followed by biliary stents (plastic or SEMS) placement. During follow-up, if stent occlusion occurs, the patient will undergo endoscopic re-intervention for stent exchange without endobiliary RFA | Procedure: Radiofrequency ablation (RFA)<br>* The RFA probe is introduced into bile duct. Bipolar electronic coagulation is performed to the tumorous segment.<br>* Other names: Endobiliary RFA;|
| No Intervention: Control group<br>Endoscopic retrograde cholangiopancreatography (ERCP) would be performed under standard operating conditions to confirm the biliary malignancy. Subjects will receive plastic biliary stent(s) placement only. Three months later, subjects will receive the second endoscopic intervention for stents (plastic or SEMS) exchange. During follow-up, if stent occlusion occurs, the patient will undergo endoscopic re-intervention for stent exchange without endobiliary RFA | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patency of stents |  | 6 months | 
| Unscheduled readmission rates |  | 6 months | 
| Serious adverse events |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholangiocarcinoma, Ampullary carcinoma, Endoscopic retrograde cholangiopancreatography, Radiofrequency ablation