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Endobiliary RFA for Unresectable Malignant Biliary Strictures

Primary Purpose

Cholangiocarcinoma, Ampullary Carcinoma

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Radiofrequency ablation (RFA)

About this trial

This is an interventional treatment trial for Cholangiocarcinoma focused on measuring Cholangiocarcinoma, Ampullary carcinoma, Endoscopic retrograde cholangiopancreatography, Radiofrequency ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Beijing Friendship Hospital Affiliated to Capital University of Medical Sciences
The First Affiliated Hospital of Guangxi Medical University
The General Hospital of Shenyang Military Region
Eastern Hepatobiliary Surgery Hospital
Xijing Hospital of the Forth Military Medical University
Hangzhou First People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Endobiliary RFA group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Patency of stents

Unscheduled readmission rates

Serious adverse events

Full Information

NCT ID

NCT01844245

First Posted

April 28, 2013

Last Updated

October 9, 2020

Sponsor

Bing Hu

1. Study Identification

Unique Protocol Identification Number

NCT01844245

Brief Title

Endobiliary RFA for Unresectable Malignant Biliary Strictures

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

May 2013 (undefined)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Bing Hu

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cholangiocarcinoma, Ampullary Carcinoma

Keywords

Cholangiocarcinoma, Ampullary carcinoma, Endoscopic retrograde cholangiopancreatography, Radiofrequency ablation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

174 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Endobiliary RFA group

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Radiofrequency ablation (RFA)

Other Intervention Name(s)

Endobiliary RFA

Intervention Description

The RFA probe is introduced into bile duct. Bipolar electronic coagulation is performed to the tumorous segment.

Primary Outcome Measure Information:

Title

Overall survival

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Patency of stents

Time Frame

6 months

Title

Unscheduled readmission rates

Time Frame

6 months

Title

Serious adverse events

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bing Hu, MD, PhD

Organizational Affiliation

Eastern Hepatobiliary Surgery Hospital, The Second Military Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Friendship Hospital Affiliated to Capital University of Medical Sciences

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100050

Country

China

Facility Name

The First Affiliated Hospital of Guangxi Medical University

City

Nanning

State/Province

Guangxi

ZIP/Postal Code

530021

Country

China

Facility Name

The General Hospital of Shenyang Military Region

City

Shenyang

State/Province

Liaoning

ZIP/Postal Code

110015

Country

China

Facility Name

Eastern Hepatobiliary Surgery Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200438

Country

China

Facility Name

Xijing Hospital of the Forth Military Medical University

City

Xi'an

State/Province

Shanxi

ZIP/Postal Code

710032

Country

China

Facility Name

Hangzhou First People's Hospital

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310006

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

33359435

Citation

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.

Results Reference

derived

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Endobiliary RFA for Unresectable Malignant Biliary Strictures

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