EUS-guided RFA for Solid Abdominal Neoplasms

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Recruiting

CT.gov ID

NCT03221335

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Digestive System Neoplasms	Device: EUS-guided RFA	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2016

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Severe adverse events [30 days]
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 [1 week]
defined as successful puncture of the lesion with the RFA needle and completion of the ablation cycle.
Procedural times [1 day]
Duration of the procedure
Hospital stay [30 days]
Duration of hospital stay after the procedure
Radiological response [1 year]
Based on a modified RECIST criterion
Number of re-interventions [1 year]
The number of re-interventions after RFA
Survival [3 years]
The duration of survival after the procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.