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Feasibility and Effectiveness of Augmented Reality Assistance System for Pancreatic Surgery

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06208579
Acronym
ARAS-P
Enrollment
20
Registered
2024-01-17
Start date
2023-09-11
Completion date
2024-11-01
Last updated
2025-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Augmented Reality, Pancreatectomy

Keywords

Augmented reality, Wearable devices, Pancreatic surgery

Brief 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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Unresectable tumors

Design outcomes

Primary

MeasureTime frame
Rate of identified peripancreatic vessels with errorsDuring surgery

Secondary

MeasureTime frameDescription
Intraoperative blood lossDuring surgery
Duration of operationDuring surgery
Duration of hospital stayThree months
User experienceDay 1User experience will be assessed using an adapted NASA Task Load Index (NASA-TLX, 5 questions, range, 1-10, with lower scores indicating lower cognitive workload)
Rate of morbidityThree monthsComplications rate after pancreatic resection
Rate of mortalityThree monthsAll cause death events
Rate of tumor-free resection marginOne weekRate of tumor-free resection margin after pancreatic resection

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026