Feasibility and Effectiveness of Augmented Reality Assistance System for Pancreatic Surgery

Pancreatectomy Clinical Trial

— ARAS-P  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06208579
• Other study ID #: 159/23
• Status: Recruiting
• Start date: September 11, 2023
• Est. completion date: May 1, 2025

Study information

• Verified date: January 2024
• Source: Klinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische Onkologie
• Contact: Gregor A. Stavrou, MD
• Phone: 0049681963 2441
• Email: gstavrou[@]klinikum-saarbruecken.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: May 1, 2025
• Est. primary completion date: February 1, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Unresectable tumors

Related Conditions & MeSH terms

• Augmented Reality
• Pancreatectomy

Locations

Country	Name	City	State
Germany	Klinikum Saarbrücken	Saarbrücken	Saarland

Sponsors (3)

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

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of identified peripancreatic vessels with errors		During surgery
Secondary	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
Secondary	Inraoperative blood loss		During surgery
Secondary	Duration of operation		During surgery
Secondary	Duration of hospital stay		Three months
Secondary	Rate of tumor-free resection margin	Rate of tumor-free resection margin after pancreatic resection	One week
Secondary	Rate of morbidity	Complications rate after pancreatic resection	Three months
Secondary	Rate of mortality	All cause death events	Three months