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临床试验/NCT06208579
NCT06208579已完成不适用

Feasibility and Effectiveness of Augmented Reality Assistance System for Pancreatic Surgery: a Prospective Study

Klinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische Onkologie1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年9月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Rate of identified peripancreatic vessels with errors

研究概览

简要总结

Pancreatic cancer necessitates surgical resection for complete tumor eradication, serving as the primary curative approach. However, pancreatic surgery is still challenging due to the organ's retroperitoneal anatomy and proximity to vital vascular systems. Thus, precise preparation and dissection of peripancreatic vessels are crucial during pancreatic surgery to reduce perioperative complications and improve oncological outcomes. The integration of preoperative computed tomography-derived reconstructed images, along with augmenting the resulting 3D model during surgical procedures, holds significant potential in this context. Augmented reality-assistance systems (ARAS) have seen use in various surgical fields, including orthopedic, plastic, and neurosurgery. Nevertheless, the application of ARAS in abdominal surgery has faced challenges related to organ shifting and deformities. The retroperitoneal nature of the pancreas, characterized by minimal intraoperative organ shifts and deformations, makes pancreatic surgery a promising candidate for ARAS. Despite this, there is a limited number of studies exploring the impact of ARAS during pancreatic surgery. Notably, existing investigations have primarily utilized augmented reality technology with 2D-display-based modalities. This prospective study aims to fill this gap by examining the usability, feasibility, and effectiveness of wearable ARAS during pancreatic surgery. By leveraging advanced technology seamlessly integrated into the surgical workflow, this research seeks to provide valuable insights into the practical application of ARAS, potentially enhancing the precision and outcomes of pancreatic surgery. The preliminary findings of this study will also be submitted for publication in a peer-reviewed journal.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Patient consent
  • Aged above 18 years
  • Undergoing any type of pancreatectomy

排除标准

  • Unresectable tumors

结局指标

主要结局

Rate of identified peripancreatic vessels with errors

时间窗: During surgery

次要结局

  • User experience(Day 1)
  • Intraoperative blood loss(During surgery)
  • Duration of operation(During surgery)
  • Duration of hospital stay(Three months)
  • Rate of tumor-free resection margin(One week)
  • Rate of morbidity(Three months)
  • Rate of mortality(Three months)

研究者

发起方
Klinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische Onkologie
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr.med Dr. habil Gregor A. Stavrou

Head of the Department

Klinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische Onkologie

研究点 (1)

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