EUS-guided RFA for Pancreatic Neoplasms

NCT ID: NCT03218345

Last Updated: 2023-08-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2024-05-31

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 pancreatic 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 neoplasms.

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

This study is a multi-center prospective study involving four high volume international institutions. Consecutive patients suffering from pancreatic neuroendocrine tumors and pancreatic cancers would be recruited. EUS-guided RFA would be performed using a 19-gauge RFA electrode and a generator. 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.

Conditions

Pancreatic Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EUS-guided RFA

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

Group Type: EXPERIMENTAL

EUS-guided RFA

Intervention Type: PROCEDURE

EUS-guided RFA would be performed using a 19-gauge RFA electrode and a generator

Interventions

EUS-guided RFA

EUS-guided RFA would be performed using a 19-gauge RFA electrode and a generator

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age 18 years-old or above
• Suffering from pancreatic neuroendocrine tumor or pancreatic ductal carcinoma (<5cm in largest diameter) that was confirmed by fine needle aspiration cytology
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Anthony Teoh

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anthony YB Teoh, Professor

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Department of Surgery, Prince of Wales Hospital

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Anthony YB Teoh, Professor

Role: CONTACT

anthonyteoh@surgery.cuhk.edu.hk

26322956

Facility Contacts

Anthony YB Teoh, FRCSEd(Gen)

Role: primary

anthonyteoh@surgery.cuhk.edu.hk

85226322953

Other Identifiers

CRE-2015.531T

Identifier Type: -

Identifier Source: org_study_id