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2017-12-20
2024-12
2024-12
30
NCT05170802
Methodist Health System
Methodist Health System
OBSERVATIONAL
Pancreatic Cancer & Surgical Resection
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.
This study is an international prospective, multi-center, registry study; collecting clinical data regarding standard-of-care use of the NanoKnife system intraoperatively (via laparotomy) to ablate the pancreatic tumors per the treating physicians discretion. NanoKnife System is a commercially available irreversible electroporation system. Since it is participants who are candidates for or undergo the NanoKnife procedure will be consented to participate in this prospective registry study. Clinical data from enrolled patients will be collected and patients will undergo clinical follow-up at the following time points post-procedure: 24-48 hours post-procedure, hospital discharge, 7 days post-procedure, 30 days, and 90 days. See Appendix 1: Schedule of Events Collected as Part of Study Registry. Participants will be followed for 4 years following the NanoKnife procedure. While in the hospital, they will be evaluated within 24-48 hours after the NanoKnife procedure. Additional assessments will be performed prior to being discharged from the hospital. Participants will be asked to return every 3 month follow up to 2 years and then every 6 months after 2 years from IRE. Each visit will last approximately two (2) to three (3) hours at the study doctor's clinic. During these visits, participants will also be asked to report any change in their medications. Except for the study visits, they will not need to visit the study doctor more often than their usual treatment unless they have other medical needs. However, if participants experience any significant change in their medical condition they may be asked to have additional tests such as CT scan, blood tests, etc. Participants will not receive any financial or other compensation for taking part in this study.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2019-11-04 | N/A | 2024-03-26 |
2021-12-09 | N/A | 2024-03-27 |
2021-12-28 | N/A | 2024-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Clinical data collected prospectively and post-operatively at different timepoints | The primary objective of the study is to collect clinical data related to treatment outcomes of Pancreatic Irreversible Electroporation in order to develop an evidence base such that physicians can provide the best possible care to patients with pancreatic cancer requiring surgical intervention. | pre-operatively and several timepoints post-operatively until 4 years |
| CBC blood test | Check participants blood counts | pre-operatively and several timepoints post-operatively until 4 years |
| Chemistry blood test | Check the elements and minerals in the blood | up to 4 years following operation |
| CA19-9 | monitor the pancreas (74U/mL) | pre-operatively and several timepoints post-operatively until 4 years |
| Physical exam-Height | Review the height of the participant using the unit of measurement of feet and inches | pre-operatively and several timepoints post-operatively until 4 years |
| Physical exam- Weight | Review the weight of participant in lbs | pre-operatively and several timepoints post-operatively until 4 years |
| CT scan of the tumor area-diameter | Longest diameter in the axial plane of the soft tissue component of the primary tumor (mm) | pre-operatively and several timepoints post-operatively until 4 years |
| CT scan of the tumor area- vessel narrowing | measurement of of the vessels (mm) by comparison of diameter from first follow up scan | pre-operatively and several timepoints post-operatively until 4 years |
| CT scan finding new lymph nodes | 15 mm short axis diameter or pathlology proven | pre-operatively and several timepoints post-operatively until 4 years |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Data on adverse events and complications related to Irreversible Electroporations. | It supports the secondary objective of the study to collect data on adverse events and complications after IRE (Irreversible Electroporation). | It will be collected at different timepoints until 4 years postoperatively. |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Crystee Cooper, DHEd Phone Number: 214-947-1280 Email: clinicalresearch@mhd.com |
Study Contact Backup Name: Zaid Haddadin, MS Phone Number: 214-947-4459 Email: clinicalresearch@mhd.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
