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Trial record 2 of 31 for:    Pancreatic Cancer | ( Map: Hong Kong )

EUS-guided RFA for Pancreatic Neoplasms

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ClinicalTrials.gov Identifier: NCT03218345
Recruitment Status : Recruiting
First Posted : July 14, 2017
Last Update Posted : December 13, 2019
Sponsor:
Information provided by (Responsible Party):
Anthony Teoh, Chinese University of Hong Kong

Tracking Information
First Submitted Date  ICMJE November 16, 2016
First Posted Date  ICMJE July 14, 2017
Last Update Posted Date December 13, 2019
Actual Study Start Date  ICMJE August 2016
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2017)
  • Technical success rates [ Time Frame: 1 week ]
    defined as successful puncture of the lesion with the RFA needle and completion of the ablation cycle.
  • Procedural times [ Time Frame: 1 day ]
    Duration of the procedure
  • Hospital stay [ Time Frame: 30 days ]
    Duration of hospital stay
  • Radiological response [ Time Frame: 1 year ]
    Based on modified RECIST criterion
  • Number of re-interventions [ Time Frame: 1 year ]
    Number of re-interventions after the procedure
  • Survival [ Time Frame: 3 years ]
    Duration of survival after the procedure
Original Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2017)
  • Technical success rates [ Time Frame: 1 week ]
    defined as successful puncture of the lesion with the RFA needle and completion of the ablation cycle.
  • Procedural times [ Time Frame: 1 day ]
    Duration of the procedure
  • Hospital stay [ Time Frame: 30 days ]
    Duration of hospital stay
  • Radiological response [ Time Frame: 1 year ]
    Based on modified RECIST criterion
  • Number of re-interventions [ Time Frame: 1 year ]
    Numer of re-interventions after the procedure
  • Survival [ Time Frame: 3 years ]
    Duration of survival after the procedure
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EUS-guided RFA for Pancreatic Neoplasms
Official Title  ICMJE Multi-center Prospective Study on EUS-guided Radiofrequency Ablation for Solid Pancreatic Neoplasms
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Neoplasms
Intervention  ICMJE Procedure: EUS-guided RFA
EUS-guided RFA would be performed using a 19-gauge RFA electrode and a generator
Study Arms  ICMJE Experimental: EUS-guided RFA
EUS-guided RFA would be performed using a 19-gauge RFA electrode and a VIVA RF generator (STARmed, Korea)
Intervention: Procedure: EUS-guided RFA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 13, 2017)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Anthony YB Teoh, Professor 26322956 anthonyteoh@surgery.cuhk.edu.hk
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03218345
Other Study ID Numbers  ICMJE CRE-2015.531T
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Anthony Teoh, Chinese University of Hong Kong
Study Sponsor  ICMJE Chinese University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anthony YB Teoh, Professor Chinese University of Hong Kong
PRS Account Chinese University of Hong Kong
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP