EUS-guided RFA for Pancreatic Neoplasms

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

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Neoplasms
• Intervention / Treatment: Procedure: 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 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.

• Study Type: Interventional
• Enrollment (Estimated): 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
    • Principal Investigator: Anthony YB Teoh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

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)	Procedure: EUS-guided RFA; EUS-guided RFA would be performed using a 19-gauge RFA electrode and a generator

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, thermal injury	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital stay	Duration of hospital stay	30 days
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
Radiological response	Based on modified RECIST criterion	1 year
Number of re-interventions	Number of re-interventions after the procedure	1 year
Survival	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): August 1, 2016
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: November 16, 2016
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (Actual): July 14, 2017

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: EUS-guided RFA; pancreatic ca; interventional EUS
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: CRE-2015.531T

Plan for Individual participant data (IPD)

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