EUS-guided RFA for Pancreatic Neoplasms

NCT03218345 | Recruiting DMC

• 1 other identifier: CRE-2015.531T
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Neoplasms

Keywords

EUS-guided RFA; pancreatic ca; interventional EUS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Technical success rates

  1 week

• Procedural times

  1 day

• Hospital stay

  30 days

• Radiological response

  1 year

• Number of re-interventions

  1 year

Study Arms (1)

EUS-guided RFA

EXPERIMENTAL

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

Procedure: EUS-guided RFA

Interventions

EUS-guided RFA PROCEDURE

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

EUS-guided RFA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Surgery, Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Anthony YB Teoh, Professor

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony YB Teoh, Professor

CONTACT

26322956; anthonyteoh@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: July 14, 2017
• Study Start: August 1, 2016
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

HK (1)