Feasibility and Effectiveness of Augmented Reality Assistance System for Pancreatic Surgery (ARAS-P)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatectomy; Augmented Reality

• Study Type: Observational
• Enrollment (Estimated): 25

Contacts and Locations

• Study Contact: Name: Gregor A. Stavrou, MD; Phone Number: 0049681963 2441; Email: gstavrou@klinikum-saarbruecken.de
• Study Contact Backup: Name: Omid Ghamar Nejad, MD; Phone Number: 0049681963 2441; Email: oghamar@klinikum-saarbruecken.de

Study Locations

• Germany
  • Saarland
    • Saarbrücken, Saarland, Germany, 66119
      • Recruiting
      • Klinikum Saarbrücken
      • Contact: Gregor A. Stavrou, Dr. Dr. habil; Phone Number: 00496819632441; Email: gstavrou@klinikum-saarbruecken.de
      • Contact: Omid Ghamar Nejad, MD; Phone Number: 00496819632441; Email: oghamar@klinikum-saarbruecken.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with any type of pancreatic tumor undergoing pancreatic surgery using an augmented reality-assistance system

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Unresectable tumors

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of identified peripancreatic vessels with errors	During surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of hospital stay		Three months
Rate of mortality	All cause death events	Three months
User experience	User experience will be assessed using an adapted NASA Task Load Index (5 questions, range, 1-10, with lower scores indicating lower cognitive workload)	Day 1
Inraoperative blood loss		During surgery
Duration of operation		During surgery
Rate of tumor-free resection margin	Rate of tumor-free resection margin after pancreatic resection	One week
Rate of morbidity	Complications rate after pancreatic resection	Three months

Collaborators and Investigators

• Sponsor: Klinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische Onkologie
• Collaborators: University of Kaiserslautern-Landau; Deutsches Forschungszentrum für Künstliche Intelligenz (DFKI)

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2023
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: December 22, 2023
• First Submitted That Met QC Criteria: January 5, 2024
• First Posted (Estimated): January 17, 2024

Study Record Updates

• Last Update Posted (Estimated): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Pancreatic surgery; Augmented reality; Wearable devices
• Other Study ID Numbers: 159/23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No