NCT01844245

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

4.6 years

First QC Date

April 28, 2013

Last Update Submit

October 9, 2020

Conditions

CholangiocarcinomaAmpullary Carcinoma

Keywords

CholangiocarcinomaAmpullary carcinomaEndoscopic retrograde cholangiopancreatographyRadiofrequency ablation

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    2 years

Secondary Outcomes (3)

  • Patency of stents

    6 months

  • Unscheduled readmission rates

    6 months

  • Serious adverse events

    30 days

Study Arms (2)

Endobiliary RFA group

EXPERIMENTAL

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)

Control group

NO INTERVENTION

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

Interventions

Radiofrequency ablation (RFA)PROCEDURE

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

Also known as: Endobiliary RFA
Endobiliary RFA group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Beijing Friendship Hospital Affiliated to Capital University of Medical Sciences

Beijing, Beijing Municipality, 100050, China

Location

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

The General Hospital of Shenyang Military Region

Shenyang, Liaoning, 110015, China

Location

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, 200438, China

Location

Xijing Hospital of the Forth Military Medical University

Xi’an, Shanxi, 710032, China

Location

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310006, China

Location

Related Publications (1)

  • 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.

    PMID: 33359435DERIVED

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Bing Hu, MD, PhD

    Eastern Hepatobiliary Surgery Hospital, The Second Military Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Head of Endoscopy Center

Study Record Dates

First Submitted

April 28, 2013

First Posted

May 1, 2013

Study Start

May 1, 2013

Primary Completion

December 1, 2017

Study Completion

July 1, 2019

Last Updated

October 14, 2020

Record last verified: 2020-10

Locations

CN(6)