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临床试验/NCT05170802
NCT05170802招募中不适用

AHPBA Registry Database (Collection of Clinical Data Related to Pancreatic Cancer & Treatment - Irreversible Electroporation (IRE))

Methodist Health System1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Chemistry blood test

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Patients who meet any of the following criteria will be excluded from the study:
  • Do not meet the Study Inclusion Criteria laid out above

结局指标

主要结局

Chemistry blood test

时间窗: up to 4 years following operation

Check the elements and minerals in the blood

CT scan of the tumor area-diameter

时间窗: 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)

Physical exam- Weight

时间窗: pre-operatively and several timepoints post-operatively until 4 years

Review the weight of participant in lbs

CT scan finding new lymph nodes

时间窗: 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

时间窗: 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

时间窗: pre-operatively and several timepoints post-operatively until 4 years

Check participants blood counts

CA19-9

时间窗: pre-operatively and several timepoints post-operatively until 4 years

monitor the pancreas (74U/mL)

CT scan of the tumor area- vessel narrowing

时间窗: 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

时间窗: 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

次要结局

  • Data on adverse events and complications related to Irreversible Electroporations.(It will be collected at different timepoints until 4 years postoperatively.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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