Pancreatic Cancer & Surgical Resection

Recruiting

• Conditions: Pancreas Cancer

• Registration Number: NCT05170802
• Lead Sponsor: Methodist Health System

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-12-20
• Study First Submitted: 2019-11-04
• Study First Submitted QC: 2021-12-09
• Study First Posted: 2021-12-28
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-27
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Chemistry blood test	up to 4 years following operation	Check the elements and minerals in the blood
Physical exam- Weight	pre-operatively and several timepoints post-operatively until 4 years	Review the weight of participant in lbs
CT scan of the tumor area-diameter	pre-operatively and several timepoints post-operatively until 4 years	Longest diameter in the axial plane of the soft tissue component of the primary tumor (mm)
CT scan finding new lymph nodes	pre-operatively and several timepoints post-operatively until 4 years	15 mm short axis diameter or pathlology proven
Clinical data collected prospectively and post-operatively at different timepoints	pre-operatively and several timepoints post-operatively until 4 years	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.
CBC blood test	pre-operatively and several timepoints post-operatively until 4 years	Check participants blood counts
CA19-9	pre-operatively and several timepoints post-operatively until 4 years	monitor the pancreas (74U/mL)
CT scan of the tumor area- vessel narrowing	pre-operatively and several timepoints post-operatively until 4 years	measurement of of the vessels (mm) by comparison of diameter from first follow up scan
Physical exam-Height	pre-operatively and several timepoints post-operatively until 4 years	Review the height of the participant using the unit of measurement of feet and inches

Secondary Outcome Measures

Name	Time	Method
Data on adverse events and complications related to Irreversible Electroporations.	It will be collected at different timepoints until 4 years postoperatively.	It supports the secondary objective of the study to collect data on adverse events and complications after IRE (Irreversible Electroporation).

Trial Locations

Locations (1)

Liver Institute of Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States