Endobiliary RFA for Unresectable Malignant Biliary Strictures

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Eastern Hepatobiliary Surgery Hospital
Sponsor:
Information provided by (Responsible Party):
Bing Hu, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier:
NCT01844245
First received: April 28, 2013
Last updated: April 21, 2014
Last verified: May 2013
  Purpose

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.


Condition Intervention
Cholangiocarcinoma
Ampullary Carcinoma
Procedure: Radiofrequency ablation (RFA)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Radiofrequency Ablation for Malignant Biliary Strictures Due to Unresectable Cholangiocarcinoma or Ampullary Carcinoma: a Randomised, Controlled, Multicentre Clinical Trial

Resource links provided by NLM:


Further study details as provided by Eastern Hepatobiliary Surgery Hospital:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Patency of stents [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Unscheduled readmission rates [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Serious adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 240
Study Start Date: May 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endobiliary RFA group
  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
Procedure: Radiofrequency ablation (RFA)
The RFA probe is introduced into bile duct. Bipolar electronic coagulation is performed to the tumorous segment.
Other Name: Endobiliary RFA
No Intervention: Control group
  1. 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.
  2. Three months later, subjects will receive the second endoscopic intervention for stents (plastic or SEMS) exchange.
  3. During follow-up, if stent occlusion occurs, the patient will undergo endoscopic re-intervention for stent exchange without endobiliary RFA

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01844245

Contacts
Contact: Bing Hu, MD, PhD +86-21-81875221 drhubing@yahoo.cn
Contact: Dao-Jian Gao, MD, PhD +86-21-81875222 gaodj1975@126.com

Locations
China, Beijing
Beijing Friendship Hospital Affiliated to Capital University of Medical Sciences Recruiting
Beijing, Beijing, China, 100050
Contact: Ming Ji, Doctor    +86-10-63138339      
Principal Investigator: Ming Ji, Doctor         
China, Guangxi
The First Affiliated Hospital of Guangxi Medical University Recruiting
Nanning, Guangxi, China, 530021
Contact: Hai-xing Jiang, M.D.    +86-771-5356725    jihaxi@163.com   
Principal Investigator: Hai-xing Jiang, M.D.         
China, Liaoning
The General Hospital of Shenyang Military Region Recruiting
Shenyang, Liaoning, China, 110015
Contact: Shu-Ren Ma, Doctor    +86-24-28886666    shuren_ma@163.com   
Principal Investigator: Shu-Ren Ma, Doctor         
China, Shanghai
Eastern Hepatobiliary Surgery Hospital Recruiting
Shanghai, Shanghai, China, 200438
Contact: Bing Hu, Doctor    +86-21-81875221    drhubing@yahoo.cn   
Contact: Dao-Jian Gao, Doctor    +86-21-81875222    gaodj1975@126.com   
Principal Investigator: Bing Hu, Doctor         
Sub-Investigator: Dao-Jian Gao, Doctor         
China, Shanxi
Xijing Hospital of the Forth Military Medical University Recruiting
Xi'an, Shanxi, China, 710032
Contact: Xue-Gang Guo, Doctor       gxuegang@fmmu.edu.cn   
Principal Investigator: Xue-Gang Guo, Doctor         
China, Zhejiang
Hangzhou First People's Hospital Recruiting
Hangzhou, Zhejiang, China, 310006
Contact: Xiao-Feng Zhang, Doctor    +86-571-87065701    zxf837@tom.com   
Principal Investigator: Xiao-Feng Zhang, Doctor         
Sponsors and Collaborators
Bing Hu
Investigators
Principal Investigator: Bing Hu, MD, PhD Eastern Hepatobiliary Surgery Hospital, The Second Military Medical University
  More Information

No publications provided

Responsible Party: Bing Hu, Professor, Head of Endoscopy Center, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier: NCT01844245     History of Changes
Other Study ID Numbers: EHBH B-RFA 2013-001
Study First Received: April 28, 2013
Last Updated: April 21, 2014
Health Authority: China: Science and Technology Commission of Shanghai Municipality

Keywords provided by Eastern Hepatobiliary Surgery Hospital:
Cholangiocarcinoma
Ampullary carcinoma
Endoscopic retrograde cholangiopancreatography
Radiofrequency ablation

Additional relevant MeSH terms:
Cholangiocarcinoma
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on September 16, 2014