EUS-guided RFA for Solid Abdominal Neoplasms

Multi-center Prospective Study on EUS-guided Radiofrequency Ablation for Solid Abdominal Neoplasms.

Radiofrequency ablation has been used for treatment of solid neoplasms of the liver, lung, kidney and adrenal. Recently, EUS-guided RFA has become available and the device allows EUS-guided treatment of solid abdominal neoplasms. The procedure has been shown to be feasible in the porcine pancreas and was used to treat small groups of patients that are not suitable for surgery suffering from pancreatic cancers.

The aim of the current study is to perform a multi-center prospective study on EUS-guided radiofrequency ablation (RFA) of solid abdominal neoplasms. The hypothesis is that EUS-guided RFA is safe, feasible and effective for treating solid abdominal neoplasms.

Study Overview

• Status: Recruiting
• Conditions: Digestive System Neoplasms
• Intervention / Treatment: Device: EUS-guided RFA

Detailed Description

RFA causes tissue destruction through the application of a high frequency alternating current, generating local temperatures above 60°C and leading to coagulative necrosis. The technique has been widely used in many solid organ tumours and has been shown to result in 5-year survival rates comparable to surgery. The technique is currently the standard therapy in hepatocellular carcinoma and colorectal pulmonary metastasis particular in patients that are not suitable for surgery.

The current study would be a multi-center prospective study involving four high volume international institutions. Consecutive patients suffering from solid neoplasms of the liver, stomach and adrenals would be recruited. EUS-guided RFA would be performed using a 19-gauge RFA electrode and a VIVA RF generator (STARmed, Korea). The primary outcome would be the overall adverse events rate. Secondary outcomes include mortality, technical success rate, completion ablation rate, 1 & 3 year overall and disease-free survival.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anthony YB Teoh, Professor; Phone Number: 26322956; Email: anthonyteoh@surgery.cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Department of Surgery, Prince of Wales Hospital
    • Contact: Anthony YB Teoh, FRCSEd(Gen); Phone Number: 85226322953; Email: anthonyteoh@surgery.cuhk.edu.hk

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:

• Age 18 years-old or above
• Suffering from solid neoplasms of the stomach, liver, kidney or adrenals (<5cm in largest diameter) that is indicated for treatment.

• Unsuitable for surgery, due to one (or more) of the following items:

  • ASA score > II*
  • An alternative advanced malignancy
  • Unsuitable for surgery upon expert's opinion for any other reason
• Healthy individuals who are not keen for surgical resection
• Eligible for endoscopic intervention
• Written informed consent

Exclusion Criteria:

• Coagulopathy (international normalized ratio >1.3, partial thromboplastin time greater than twice that of control), platelet count <50,000x103/uL
• Pregnancy
• Patients with a poor mental condition or mental retardation, unable to understand the nature and possible consequences of the study
• Patients unwilling to undergo follow-up assessments
• Patients with liver cirrhosis, portal hypertension and/or gastric varices.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: EUS-guided RFA; EUS-guided RFA would be performed using a 19-gauge RFA electrode and a VIVA RF generator (STARmed, Korea).

Device: EUS-guided RFA; All patients would undergo EUS with a linear array echoendoscope. The location and size of the lesion would be assessed for suitability of treatment. After locating the lesion, the RFA needle would be inserted to the centre of the lesion. RFA would then be initiated and hyperechoic interferences would be observed around the electrode signifying heating of the tissue. The duration of ablation would be according to the size of the lesion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe adverse events	Adverse events specific to RFA would be graded according to the lexicon of endoscopic adverse events 24. Potential adverse events specific to RFA include: post-RFA syndrome, pancreatitis, pancreatic leak and thermal injury.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success rates	defined as successful puncture of the lesion with the RFA needle and completion of the ablation cycle.	1 week
Procedural times	Duration of the procedure	1 day
Hospital stay	Duration of hospital stay after the procedure	30 days
Radiological response	Based on a modified RECIST criterion	1 year
Number of re-interventions	The number of re-interventions after RFA	1 year
Survival	The duration of survival after the procedure	3 years

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Anthony YB Teoh, Professor, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2016
• Primary Completion (ANTICIPATED): April 1, 2024
• Study Completion (ANTICIPATED): April 1, 2024

Study Registration Dates

• First Submitted: November 16, 2016
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (ACTUAL): July 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: liver; adrenal; stomach; EUS-guided RFA; kidney tumour
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Gastrointestinal Diseases; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Abdominal Neoplasms
• Other Study ID Numbers: CRE-2015.707

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED