Endoscopic Radiofrequency Ablation for Malignant Biliary Strictures Due to Unresectable Cholangiocarcinoma or Ampullary Carcinoma: a Randomised, Controlled, Multicentre Clinical Trial
18 Years
N/A
Both
Cholangiocarcinoma, Ampullary Carcinoma
Trial Information
Endoscopic Radiofrequency Ablation for Malignant Biliary Strictures Due to Unresectable Cholangiocarcinoma or Ampullary Carcinoma: a Randomised, Controlled, Multicentre Clinical Trial
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Outcome Time Frame:
2 years
Safety Issue:
Yes
Principal Investigator
Bing Hu, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Eastern Hepatobiliary Surgery Hospital, The Second Military Medical University
Authority:
China: Science and Technology Commission of Shanghai Municipality
Study ID:
EHBH B-RFA 2013-001
NCT ID:
NCT01844245
Start Date:
May 2013
Completion Date:
May 2015
Related Keywords:
- Cholangiocarcinoma
- Ampullary Carcinoma
- Cholangiocarcinoma
- Ampullary carcinoma
- Endoscopic retrograde cholangiopancreatography
- Radiofrequency ablation
- Carcinoma
- Cholangiocarcinoma
- Cholestasis
- Constriction, Pathologic
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