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OpenTrials
Completed

NCT Number: NCT06208579

Feasibility and Effectiveness of Augmented Reality Assistance System for Pancreatic Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Saarbrücken

Saarbrücken, Saarland, 66119, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Unresectable tumors

Treatment and study plan

Primary outcomes

  1. Rate of identified peripancreatic vessels with errors

    Time frame: During surgery

Secondary outcomes

  1. User experience

    Time frame: Day 1

    User 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)

  2. Intraoperative blood loss

    Time frame: During surgery

  3. Duration of operation

    Time frame: During surgery

  4. Duration of hospital stay

    Time frame: Three months

  5. Rate of tumor-free resection margin

    Time frame: One week

    Rate of tumor-free resection margin after pancreatic resection

  6. Rate of morbidity

    Time frame: Three months

    Complications rate after pancreatic resection

  7. Rate of mortality

    Time frame: Three months

    All cause death events

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Deutsches Forschungszentrum für Künstliche Intelligenz (DFKI)
  • University of Kaiserslautern-Landau

Registry information

Official study title

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

Acronym: ARAS-P

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 17, 2024
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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