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EUS-guided RFA for Pancreatic Neoplasms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03218345
Recruitment Status : Recruiting
First Posted : July 14, 2017
Last Update Posted : December 13, 2019
Information provided by (Responsible Party):
Anthony Teoh, Chinese University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Pancreatic Neoplasms Procedure: EUS-guided RFA Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 Pancreatic Neoplasms
Actual Study Start Date : August 2016
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Severe adverse events [ Time Frame: 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, thermal injury

Secondary Outcome Measures :
  1. Technical success rates [ Time Frame: 1 week ]
    defined as successful puncture of the lesion with the RFA needle and completion of the ablation cycle.

  2. Procedural times [ Time Frame: 1 day ]
    Duration of the procedure

  3. Hospital stay [ Time Frame: 30 days ]
    Duration of hospital stay

  4. Radiological response [ Time Frame: 1 year ]
    Based on modified RECIST criterion

  5. Number of re-interventions [ Time Frame: 1 year ]
    Number of re-interventions after the procedure

  6. Survival [ Time Frame: 3 years ]
    Duration of survival after the procedure

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03218345

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Contact: Anthony YB Teoh, Professor 26322956

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Hong Kong
Department of Surgery, Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Anthony YB Teoh, FRCSEd(Gen)    85226322953   
Principal Investigator: Anthony YB Teoh         
Sponsors and Collaborators
Chinese University of Hong Kong
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Principal Investigator: Anthony YB Teoh, Professor Chinese University of Hong Kong
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Responsible Party: Anthony Teoh, Associate Professor, Chinese University of Hong Kong Identifier: NCT03218345    
Other Study ID Numbers: CRE-2015.531T
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Anthony Teoh, Chinese University of Hong Kong:
EUS-guided RFA
pancreatic ca
interventional EUS
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases