Pancreas CancerNCT05170802
Pancreatic Cancer & Surgical Resection
An observational study of Pancreas Cancer, run by Methodist Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- NanoKnife procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2017to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- more than 18 years of age
- Diagnosed with pancreatic cancer and has consented to undergo the NanoKnife procedure per the treating physician
- Willing and able to comply with the protocol requirements
- Able to comprehend and sign the Informed Consent Form in English or Spanish
Who cannot join
- Patients who meet any of the following criteria will be excluded from the study:
- Do not meet the Study Inclusion Criteria laid out above
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Liver Institute of Methodist Dallas Medical Center
Dallas, Texas, 75203
Alejandro Mejia, MD, 214-947-4400, AlejandroMejia@mhd.com
About this study
Official title: AHPBA Registry Database (Collection of Clinical Data Related to Pancreatic Cancer & Treatment - Irreversible Electroporation (IRE))
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.
Read the 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.
- Conditions
- Pancreas Cancer
- Being tested
- NanoKnife procedure
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NanoKnife procedureOther
clinical data regarding use of the NanoKnife system intraoperatively (via laparotomy) to ablate the pancreatic tumors per the treating physicians discretion will be collected.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre-operatively and several timepoints post-operatively until 4 years
CBC blood test
Check participants blood counts
Measured: pre-operatively and several timepoints post-operatively until 4 years
Chemistry blood test
Check the elements and minerals in the blood
Measured: up to 4 years following operation
CA19-9
monitor the pancreas (74U/mL)
Measured: 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
Measured: pre-operatively and several timepoints post-operatively until 4 years
Physical exam- Weight
Review the weight of participant in lbs
Measured: 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)
Measured: 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
Measured: pre-operatively and several timepoints post-operatively until 4 years
CT scan finding new lymph nodes
15 mm short axis diameter or pathlology proven
Measured: pre-operatively and several timepoints post-operatively until 4 years
Secondary outcomes (1)
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).
Measured: It will be collected at different timepoints until 4 years postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start20 Dec 2017
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alejandro Mejia, M.D., Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170802
- Sponsor's protocol ID
- 036.HPB.2017.D
- Status last verified
- Mar 2024
- First submitted
- 4 Nov 2019
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AHPBA Registry Database (Collection of Clinical Data Related to Pancreatic Cancer & Treatment - Irreversible Electroporation (IRE))
- ClinicalTrials.gov ID
- NCT05170802
- Acronym / sponsor ID
- 036.HPB.2017.D
- Conditions
- Pancreas Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- more than 18 years of age
- Diagnosed with pancreatic cancer and has consented to undergo the NanoKnife procedure per the treating physician
- Willing and able to comply with the protocol requirements
- Able to comprehend and sign the Informed Consent Form in English or Spanish
Key exclusion criteria (2 listed)
- Patients who meet any of the following criteria will be excluded from the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NanoKnife procedureclinical data regarding use of the NanoKnife system intraoperatively (via laparotomy) to ablate the pancreatic tumors per the treating physicians discretion will be collected. | Other | – |
Primary outcome
Clinical data collected prospectively and post-operatively at different timepoints
Time frame: 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
Time frame: pre-operatively and several timepoints post-operatively until 4 years
Check participants blood counts
Chemistry blood test
Time frame: up to 4 years following operation
Check the elements and minerals in the blood
CA19-9
Time frame: pre-operatively and several timepoints post-operatively until 4 years
monitor the pancreas (74U/mL)
Physical exam-Height
Time frame: 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
Physical exam- Weight
Time frame: pre-operatively and several timepoints post-operatively until 4 years
Review the weight of participant in lbs
CT scan of the tumor area-diameter
Time frame: 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 of the tumor area- vessel narrowing
Time frame: 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
CT scan finding new lymph nodes
Time frame: pre-operatively and several timepoints post-operatively until 4 years
15 mm short axis diameter or pathlology proven
1 secondary outcome
Data on adverse events and complications related to Irreversible Electroporations.
Time frame: It will be collected at different timepoints until 4 years postoperatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandro Mejia, M.D. principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Cancer, run by Methodist Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Crystee Cooper, DHEd (214-947-1280, clinicalresearch@mhd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024; AzTrials last refreshed its copy on 6 Nov 2026.