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EUS-guided RFA for Solid Abdominal Neoplasms

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ClinicalTrials.gov Identifier: NCT03221335
Recruitment Status : Recruiting
First Posted : July 18, 2017
Last Update Posted : November 15, 2018
Sponsor:
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 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.


Condition or disease Intervention/treatment Phase
Digestive System Neoplasms Device: 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 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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 Abdominal Neoplasms.
Study Start Date : May 2016
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

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).
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.




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 and 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 after the procedure

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

  5. Number of re-interventions [ Time Frame: 1 year ]
    The number of re-interventions after RFA

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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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 ClinicalTrials.gov identifier (NCT number): NCT03221335


Contacts
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Contact: Anthony YB Teoh, Professor 26322956 anthonyteoh@surgery.cuhk.edu.hk

Locations
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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    anthonyteoh@surgery.cuhk.edu.hk   
Principal Investigator: Anthony YB Teoh         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Anthony YB Teoh, Professor Chinese University of Hong Kong

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Responsible Party: Anthony Teoh, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03221335     History of Changes
Other Study ID Numbers: CRE-2015.707
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Anthony Teoh, Chinese University of Hong Kong:
EUS-guided RFA
liver
stomach
adrenal
kidney tumour
Additional relevant MeSH terms:
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Digestive System Neoplasms
Gastrointestinal Neoplasms
Abdominal Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases