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

April 28, 2013
April 21, 2014
May 2013
October 2014   (final data collection date for primary outcome measure)
Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01844245 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Endobiliary RFA for Unresectable Malignant Biliary Strictures
Endoscopic Radiofrequency Ablation for Malignant Biliary Strictures Due to Unresectable Cholangiocarcinoma or Ampullary Carcinoma: a Randomised, Controlled, Multicentre Clinical Trial

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cholangiocarcinoma
  • Ampullary Carcinoma
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
  • 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
    Intervention: Procedure: Radiofrequency ablation (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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
May 2015
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Bing Hu, MD, PhD +86-21-81875221 drhubing@yahoo.cn
Contact: Dao-Jian Gao, MD, PhD +86-21-81875222 gaodj1975@126.com
China
 
NCT01844245
EHBH B-RFA 2013-001
No
Bing Hu, Eastern Hepatobiliary Surgery Hospital
Bing Hu
Not Provided
Principal Investigator: Bing Hu, MD, PhD Eastern Hepatobiliary Surgery Hospital, The Second Military Medical University
Eastern Hepatobiliary Surgery Hospital
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP