Clinical trial NCT05170802: Pancreatic Cancer & Surgical Resection
Official title: AHPBA Registry Database (Collection of Clinical Data Related to Pancreatic Cancer & Treatment - Irreversible Electroporation (IRE))
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreas Cancer
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2021-12-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: clinical data regarding use of the NanoKnife system intraoperatively (via laparotomy) to ablate the pancreatic tumors per the treating physicians discretion will be collected.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical data collected prospectively and post-operatively at different timepoints
timeFrame: pre-operatively and several timepoints post-operatively until 4 years
measure: CBC blood test
timeFrame: pre-operatively and several timepoints post-operatively until 4 years
measure: Chemistry blood test
timeFrame: up to 4 years following operation
measure: CA19-9
timeFrame: pre-operatively and several timepoints post-operatively until 4 years
measure: Physical exam-Height
timeFrame: pre-operatively and several timepoints post-operatively until 4 years
measure: Physical exam- Weight
timeFrame: pre-operatively and several timepoints post-operatively until 4 years
measure: CT scan of the tumor area-diameter
timeFrame: pre-operatively and several timepoints post-operatively until 4 years
measure: CT scan of the tumor area- vessel narrowing
timeFrame: pre-operatively and several timepoints post-operatively until 4 years
measure: CT scan finding new lymph nodes
timeFrame: pre-operatively and several timepoints post-operatively until 4 years
Secondary outcomes:
measure: Data on adverse events and complications related to Irreversible Electroporations.
timeFrame: It will be collected at different timepoints until 4 years postoperatively.
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Liver Institute of Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Alejandro Mejia, M.D.
role: PRINCIPAL_INVESTIGATOR
References: