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A Clinical Study of EUS-RFA for Inoperable Pancreatic Ductal Adenocarcinoma (EUS-RFA)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03444948
Recruitment Status : Suspended (There was a voluntary recall from the Habib EUS RFA device manufacturer)
First Posted : February 26, 2018
Last Update Posted : May 26, 2020
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

Brief Summary:
To assess if endoscopic ultrasound-guided radiofrequency ablation application in patients with inoperable pancreatic cancer confers survival benefit when compared to patients receiving standard medical care.

Condition or disease Intervention/treatment Phase
Pancreatic Ductal Adenocarcinoma Device: EUS-RFA using Habib Tm as a probe Procedure: EUS Not Applicable

Detailed Description:
The five-year survival for pancreatic ductal adenocarcinoma (PDAC) is less than 5% in spite of the advances in management of cancers in the last few decades. Endobiliary application of radiofrequency (RF) has been developed and used in patients with inoperable bile duct and pancreatic head adenocarcinomas presenting with biliary obstruction. (1, 2) Endoscopic ultrasound (EUS) radiofrequency ablation (RFA) of pancreatic neoplasms has been proven to be well tolerated and safe, inducing a significant reduction in tumour size (3). Various techniques of EUS-guided tumour ablation have been described, including RF ablation, photodynamic therapy, laser ablation, and ethanol injection (4). Kahaleh et al. have demonstrated that Endoscopic ultrasound guided RF ablation (EUS-RFA) of the pancreatic head using Habib EUS-RFA catheter (EMcision Ltd, UK) through a 19-gauge needle was well tolerated in 5 Yucatan pigs and with minimum amount of pancreatitis (5). In a pilot clinical study, Pai et al showed either a complete response or at least a 50% reduction in tumours following application of radiofrequency ablation with the Habib™ EUS-RFA device in a group of eight patients with pancreatic cancers (3).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Prospective Randomised Clinical Study of Endoscopic Ultrasound Guided Radiofrequency Ablation (EUS-RFA) for Inoperable Pancreatic Ductal Adenocarcinoma
Actual Study Start Date : February 14, 2019
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : December 1, 2022

Arm Intervention/treatment
Experimental: 3 radiofrequency ablation procedures
Subject will undergo 3 radiofrequency ablation procedures at 1 month intervals (EUS-RFA using Habib Tm as a probe)
Device: EUS-RFA using Habib Tm as a probe
3 EUS-RFA interventions at 1-month interval

Active Comparator: standard medical care
Subject will receive standard medical care, including pain relief drugs
Procedure: EUS
Standard intervention




Primary Outcome Measures :
  1. Survival [ Time Frame: 1 month ]
    Duration of survival

  2. Survival [ Time Frame: at time of death on average 10months ]
    Duration of survival


Secondary Outcome Measures :
  1. Quality of life (HEALTH, SOCIAL INTERACTIONS, DAILY ACTIVITIES) [ Time Frame: 1 month ]
    Quality of life questionnaire DDQ15

  2. Quality of life (HEALTH, SOCIAL INTERACTIONS, DAILY ACTIVITIES) [ Time Frame: Time of death on average 10 months ]
    Quality of life questionnaire DDQ15

  3. Pain reduction [ Time Frame: 1 month ]
    Likert Scale

  4. Pain reduction [ Time Frame: Time of death on average 10months ]
    Likert Scale

  5. Tumour Size [ Time Frame: 4 months ]
    Measures during follow-upEUS

  6. Monitoring of Adverse reactions [ Time Frame: At time of death on average 10months ]
    Number of participants with treatment-related adverse events will be recorded



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:   No
Criteria

Inclusion Criteria:

  • Patients above 18 years of age.
  • A cytological / histological diagnosis of inoperable PDAC based on multidisciplinary review of cross-sectional imaging and cytology / histology results.
  • Patients ought to be fit enough to be considered for the study (ECOG (Eastern Cooperative Oncology Group) performance status 0, 1 or 2)
  • Patients who have commenced chemotherapy are not excluded from the study
  • Patients capable of giving informed consent
  • Negative blood pregnancy test for women of childbearing potential
  • Willingness and ability to comply with all protocol requirements including scheduled visits, treatment plans, laboratory tests and other study procedures.

Exclusion Criteria:

  • ECOG performance status 3 or 4
  • Life expectancy less than 3 months (including liver metastases, carcinomatosis)
  • Prior investigational drugs within the last 30 days
  • Known infection with human immunodeficiency virus (HIV)

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): NCT03444948


Locations
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Canada, Quebec
Centre de recherche du Centre hospitalier de l'université de Montréal
Montréal, Quebec, Canada, H2X 0A9
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
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Principal Investigator: ANAND V SAHAI, MD Centre de Recherche du Centre Hospitalier de l'Université de Montréal
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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT03444948    
Obsolete Identifiers: NCT03065985
Other Study ID Numbers: CE 17.215
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: May 26, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms