Recruiting

Pancreatic Cancer

Sponsor:

Methodist Health System

Code:

NCT05170802

Conditions

Pancreas Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NanoKnife procedure

Study Details

Brief summary:

Primary Objective(s) To collect clinical data related to the treatment outcomes of Pancreatic IRE in order to develop an evidence base such that physicians can provide the best possible care to patients with pancreatic cancer requiring surgical intervention.

Secondary Objective(s) To collect data on adverse events and complications related to IRE treatment. The AHPBA (Americas Hepato-Pancreato-Biliary Association) will be responsible for data collection and will periodically audit the data for quality assurance purposes. The AHPBA will review outcomes reported by each participating Research Institution and if outcomes are in the lower percentile, the investigators will be offered support to analyze the reasons for the suboptimal outcomes and may seek support to improve outcomes. The participating Research Institutions will receive a certificate annually that acknowledges their participation in the Research Project.

Conditions

Pancreas Cancer

Study ID

NCT05170802

Start date

Dec 20, 2017

Status verified date

Mar, 2024

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. more than 18 years of age
2. Diagnosed with pancreatic cancer and has consented to undergo the NanoKnife procedure per the treating physician
3. Willing and able to comply with the protocol requirements
4. Able to comprehend and sign the Informed Consent Form in English or Spanish

Exclusion Criteria:

  • Patients who meet any of the following criteria will be excluded from the study:

1. Do not meet the Study Inclusion Criteria laid out above

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Interventions

NanoKnife procedure

clinical data regarding use of the NanoKnife system intraoperatively (via laparotomy) to ablate the pancreatic tumors per the treating physicians discretion will be collected.

Primary outcome measure

  • Clinical data collected prospectively and post-operatively at different timepoints [ Time Frame: pre-operatively and several timepoints post-operatively until 4 years ]
  • CBC blood test [ Time Frame: pre-operatively and several timepoints post-operatively until 4 years ]
  • Chemistry blood test [ Time Frame: up to 4 years following operation ]
  • CA19-9 [ Time Frame: pre-operatively and several timepoints post-operatively until 4 years ]
  • Physical exam-Height [ Time Frame: pre-operatively and several timepoints post-operatively until 4 years ]
  • Physical exam- Weight [ Time Frame: pre-operatively and several timepoints post-operatively until 4 years ]
  • CT scan of the tumor area-diameter [ Time Frame: pre-operatively and several timepoints post-operatively until 4 years ]
  • CT scan of the tumor area- vessel narrowing [ Time Frame: pre-operatively and several timepoints post-operatively until 4 years ]
  • CT scan finding new lymph nodes [ Time Frame: pre-operatively and several timepoints post-operatively until 4 years ]

Central Contacts and Locations

Central contacts

Crystee Cooper, DHEd

214-947-1280clinicalresearch@mhd.com

Zaid Haddadin, MS

214-947-4459clinicalresearch@mhd.com

Locations

Liver Institute of Methodist Dallas Medical Center

Recruiting

Dallas, Texas, United States, 75203

Contacts

Alejandro Mejia, MD

214-947-4400AlejandroMejia@mhd.com

More Information

Sponsor

Methodist Health System

Last update posted

Mar 27, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Methodist Health System on 2024-03-27.