Endobiliary RFA for Unresectable Malignant Biliary Strictures

Cholangiocarcinoma Clinical Trial

Official title:

Endoscopic Radiofrequency Ablation for Malignant Biliary Strictures Due to Unresectable Cholangiocarcinoma or Ampullary Carcinoma: a Randomised, Controlled, Multicentre Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01844245
• Other study ID #: EHBH B-RFA 2013-001
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: July 2019

Study information

• Verified date: October 2020
• Source: Eastern Hepatobiliary Surgery Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: July 2019
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ampullary Carcinoma
• Carcinoma
• Cholangiocarcinoma

Intervention

Procedure:
• Radiofrequency ablation (RFA)
The RFA probe is introduced into bile duct. Bipolar electronic coagulation is performed to the tumorous segment.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital Affiliated to Capital University of Medical Sciences	Beijing	Beijing
China	Hangzhou First People's Hospital	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	Eastern Hepatobiliary Surgery Hospital	Shanghai	Shanghai
China	The General Hospital of Shenyang Military Region	Shenyang	Liaoning
China	Xijing Hospital of the Forth Military Medical University	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Bing Hu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		2 years
Secondary	Patency of stents		6 months
Secondary	Unscheduled readmission rates		6 months
Secondary	Serious adverse events		30 days