Status:
COMPLETED
Endobiliary RFA for Unresectable Malignant Biliary Strictures
Lead Sponsor:
Bing Hu
Conditions:
Cholangiocarcinoma
Ampullary Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 approac...
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 appro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2019
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT01844245
Start Date
May 1 2013
End Date
July 1 2019
Last Update
October 14 2020
Active Locations (6)
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1
Beijing Friendship Hospital Affiliated to Capital University of Medical Sciences
Beijing, Beijing Municipality, China, 100050
2
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
3
The General Hospital of Shenyang Military Region
Shenyang, Liaoning, China, 110015
4
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai Municipality, China, 200438