Clinical trial NCT01844245: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cholangiocarcinoma
Ampullary Carcinoma
Keywords: Cholangiocarcinoma
Ampullary carcinoma
Endoscopic retrograde cholangiopancreatography
Radiofrequency ablation
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
First posted: 2013-05-01
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overall survival
timeFrame: 2 years
Secondary outcomes:
measure: Patency of stents
timeFrame: 6 months
measure: Unscheduled readmission rates
timeFrame: 6 months
measure: Serious adverse events
timeFrame: 30 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital Affiliated to Capital University of Medical Sciences
state: Beijing
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Shenyang
country: China
facility: The General Hospital of Shenyang Military Region
state: Liaoning
city: Shanghai
country: China
facility: Eastern Hepatobiliary Surgery Hospital
state: Shanghai
city: Xi'an
country: China
facility: Xijing Hospital of the Forth Military Medical University
state: Shanxi
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
state: Zhejiang
Study officials:
affiliation: Eastern Hepatobiliary Surgery Hospital, The Second Military Medical University
name: Bing Hu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.