EUS-guided RFA for Solid Abdominal Neoplasms

Digestive System Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03221335
• Other study ID #: CRE-2015.707
• Status: Recruiting
• Phase: N/A
• Start date: May 2016
• Est. completion date: April 2024

Study information

• Verified date: February 2023
• Source: Chinese University of Hong Kong
• Contact: Anthony YB Teoh, Professor
• Phone: 26322956
• Email: anthonyteoh[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Neoplasms
• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	Department of Surgery, Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

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