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Endobiliary RFA for Unresectable Malignant Biliary Strictures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01844245
Recruitment Status : Recruiting
First Posted : May 1, 2013
Last Update Posted : February 6, 2018
Information provided by (Responsible Party):
Bing Hu, Eastern Hepatobiliary Surgery Hospital

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.

Condition or disease Intervention/treatment Phase
Cholangiocarcinoma Ampullary Carcinoma Procedure: Radiofrequency ablation (RFA) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2013
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Overall survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Patency of stents [ Time Frame: 6 months ]
  2. Unscheduled readmission rates [ Time Frame: 6 months ]
  3. Serious adverse events [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01844245

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Contact: Bing Hu, MD, PhD +86-21-81875221
Contact: Dao-Jian Gao, MD, PhD +86-21-81875222

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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   
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   
Principal Investigator: Shu-Ren Ma, Doctor         
China, Shanghai
Eastern Hepatobiliary Surgery Hospital Recruiting
Shanghai, Shanghai, China, 200438
Contact: Bing Hu, Doctor    +86-21-81875221   
Contact: Dao-Jian Gao, Doctor    +86-21-81875222   
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   
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   
Principal Investigator: Xiao-Feng Zhang, Doctor         
Sponsors and Collaborators
Bing Hu
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Principal Investigator: Bing Hu, MD, PhD Eastern Hepatobiliary Surgery Hospital, The Second Military Medical University

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Responsible Party: Bing Hu, Professor, Head of Endoscopy Center, Eastern Hepatobiliary Surgery Hospital Identifier: NCT01844245     History of Changes
Other Study ID Numbers: EHBH B-RFA 2013-001
First Posted: May 1, 2013    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018

Keywords provided by Bing Hu, Eastern Hepatobiliary Surgery Hospital:
Ampullary carcinoma
Endoscopic retrograde cholangiopancreatography
Radiofrequency ablation

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