Back to resultsEUS-guided RFA for Solid Abdominal Neoplasms
Primary Purpose
Digestive System Neoplasms
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
EUS-guided RFA
Sponsored by
About this trial
This is an interventional treatment trial for Digestive System Neoplasms focused on measuring EUS-guided RFA, liver, stomach, adrenal, kidney tumour
Eligibility Criteria
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.
Sites / Locations
- Department of Surgery, Prince of Wales HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EUS-guided RFA
Arm Description
EUS-guided RFA would be performed using a 19-gauge RFA electrode and a VIVA RF generator (STARmed, Korea).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Technical success rates
defined as successful puncture of the lesion with the RFA needle and completion of the ablation cycle.
Procedural times
Duration of the procedure
Hospital stay
Duration of hospital stay after the procedure
Radiological response
Based on a modified RECIST criterion
Number of re-interventions
The number of re-interventions after RFA
Survival
The duration of survival after the procedure
Full Information
NCT ID
NCT03221335
First Posted
November 16, 2016
Last Updated
February 6, 2023
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT03221335
Brief Title
EUS-guided RFA for Solid Abdominal Neoplasms
Official Title
Multi-center Prospective Study on EUS-guided Radiofrequency Ablation for Solid Abdominal Neoplasms.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2016 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Digestive System Neoplasms
Keywords
EUS-guided RFA, liver, stomach, adrenal, kidney tumour
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EUS-guided RFA
Arm Type
Experimental
Arm Description
EUS-guided RFA would be performed using a 19-gauge RFA electrode and a VIVA RF generator (STARmed, Korea).
Intervention Type
Device
Intervention Name(s)
EUS-guided RFA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Severe adverse events
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Technical success rates
Description
defined as successful puncture of the lesion with the RFA needle and completion of the ablation cycle.
Time Frame
1 week
Title
Procedural times
Description
Duration of the procedure
Time Frame
1 day
Title
Hospital stay
Description
Duration of hospital stay after the procedure
Time Frame
30 days
Title
Radiological response
Description
Based on a modified RECIST criterion
Time Frame
1 year
Title
Number of re-interventions
Description
The number of re-interventions after RFA
Time Frame
1 year
Title
Survival
Description
The duration of survival after the procedure
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anthony YB Teoh, Professor
Phone
26322956
Email
anthonyteoh@surgery.cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony YB Teoh, Professor
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony YB Teoh, FRCSEd(Gen)
Phone
85226322953
Email
anthonyteoh@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Anthony YB Teoh
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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EUS-guided RFA for Solid Abdominal Neoplasms
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