Clinical trial NCT06208579: Feasibility and Effectiveness of Augmented Reality Assistance System for Pancreatic Surgery
Official title: Feasibility and Effectiveness of Augmented Reality Assistance System for Pancreatic Surgery: a Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatectomy
Augmented Reality
Keywords: Augmented reality
Wearable devices
Pancreatic surgery
Lead sponsor: Klinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische Onkologie
Sponsor class: OTHER
Collaborators: name: Deutsches Forschungszentrum für Künstliche Intelligenz (DFKI)
name: University of Kaiserslautern-Landau
First posted: 2024-01-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with any type of pancreatic tumor undergoing pancreatic surgery using an augmented reality-assistance system

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Unresectable tumors

Primary outcomes:
measure: Rate of identified peripancreatic vessels with errors
timeFrame: During surgery
Secondary outcomes:
measure: User experience
timeFrame: Day 1
measure: Intraoperative blood loss
timeFrame: During surgery
measure: Duration of operation
timeFrame: During surgery
measure: Duration of hospital stay
timeFrame: Three months
measure: Rate of tumor-free resection margin
timeFrame: One week
measure: Rate of morbidity
timeFrame: Three months
measure: Rate of mortality
timeFrame: Three months
Other outcomes:
Locations:
city: Saarbrücken
country: Germany
facility: Klinikum Saarbrücken
state: Saarland
Study officials:
References: