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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06208579
Other study ID # 159/23
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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