Endoscopic Radiofrequency Ablation for Malignant Biliary Strictures Due to Unresectable Cholangiocarcinoma or Ampullary Carcinoma: a Randomised, Controlled, Multicentre Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 174
- Locations
- 6
- Primary Endpoint
- Overall survival
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Overall survival
Time Frame: 2 years
Secondary Outcomes
- Serious adverse events(30 days)
- Unscheduled readmission rates(6 months)
- Patency of stents(6 months)
Investigators
Bing Hu
Professor, Head of Endoscopy Center
Eastern Hepatobiliary Surgery Hospital