Feasibility and Effectiveness of Augmented Reality Assistance System for Pancreatic Surgery

NCT06208579 | Completed DMC

• 1 other identifier: 159/23
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatectomy; Augmented Reality

Keywords

Augmented reality; Wearable devices; Pancreatic surgery

Outcome Measures

Primary Outcomes (1)

• Rate of identified peripancreatic vessels with errors

  During surgery

Secondary Outcomes (7)

• User experience

  Day 1

• Intraoperative blood loss

  During surgery

• Duration of operation

  During surgery

• Duration of hospital stay

  Three months

• Rate of tumor-free resection margin

  One week

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Unresectable tumors

Sponsors & Collaborators

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

Study Sites (1)

Klinikum Saarbrücken

Saarbrücken, Saarland, 66119, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, resected pancreas specimen

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 17, 2024
• Study Start: September 11, 2023
• Primary Completion: September 1, 2024
• Study Completion: November 1, 2024
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)