Pancreatic Cancer & Surgical Resection

NCT05170802 | Recruiting

• 1 other identifier: 036.HPB.2017.D
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (1)

• Data on adverse events and complications related to Irreversible Electroporations.

  It will be collected at different timepoints until 4 years postoperatively.

Interventions

NanoKnife procedure OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Liver Institute of Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Alejandro Mejia, M.D.

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Crystee Cooper, DHEd

CONTACT

214-947-1280; clinicalresearch@mhd.com

Zaid Haddadin, MS

CONTACT

214-947-4459; clinicalresearch@mhd.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: December 28, 2021
• Study Start: December 20, 2017
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 27, 2024

Record last verified: 2024-03

Locations

US (1)