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.

Study Overview

• Status: Completed
• Conditions: Cholangiocarcinoma; Ampullary Carcinoma
• Intervention / Treatment: Procedure: Radiofrequency ablation (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.

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Beijing Friendship Hospital Affiliated to Capital University of Medical Sciences
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • The First Affiliated Hospital of Guangxi Medical University
  • Liaoning
    • Shenyang, Liaoning, China, 110015
      • The General Hospital Of Shenyang Military Region
  • Shanghai
    • Shanghai, Shanghai, China, 200438
      • Eastern Hepatobiliary Surgery Hospital
  • Shanxi
    • Xi'an, Shanxi, China, 710032
      • Xijing Hospital of the Forth Military Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Hangzhou First People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Endobiliary RFA group; 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.; Three months later, subjects will receive the second RFA therapy followed by biliary stents (plastic or SEMS) placement.; 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 Names: Endobiliary RFA
NO_INTERVENTION: Control group; 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.; Three months later, subjects will receive the second endoscopic intervention for stents (plastic or SEMS) exchange.; During follow-up, if stent occlusion occurs, the patient will undergo endoscopic re-intervention for stent exchange without endobiliary RFA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Serious adverse events	30 days
Patency of stents	6 months
Unscheduled readmission rates	6 months

Collaborators and Investigators

• Sponsor: Bing Hu
• Investigators: Principal Investigator: Bing Hu, MD, PhD, Eastern Hepatobiliary Surgery Hospital, The Second Military Medical University

Publications and helpful links

General Publications

• Gao DJ, Yang JF, Ma SR, Wu J, Wang TT, Jin HB, Xia MX, Zhang YC, Shen HZ, Ye X, Zhang XF, Hu B. Endoscopic radiofrequency ablation plus plastic stent placement versus stent placement alone for unresectable extrahepatic biliary cancer: a multicenter randomized controlled trial. Gastrointest Endosc. 2021 Jul;94(1):91-100.e2. doi: 10.1016/j.gie.2020.12.016. Epub 2020 Dec 24.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (ACTUAL): December 1, 2017
• Study Completion (ACTUAL): July 1, 2019

Study Registration Dates

• First Submitted: April 28, 2013
• First Submitted That Met QC Criteria: April 30, 2013
• First Posted (ESTIMATE): May 1, 2013

Study Record Updates

• Last Update Posted (ACTUAL): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 9, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Cholangiocarcinoma; Radiofrequency ablation; Endoscopic retrograde cholangiopancreatography; Ampullary carcinoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Carcinoma; Cholangiocarcinoma
• Other Study ID Numbers: EHBH B-RFA 2013-001