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Clinical Trials/NCT07378345
NCT07378345CompletedNot Applicable

Digitization and Optimization of Communication Between Surgery and Pathology in the Resection of Head and Neck Tumors

Heidelberg University1 site in 1 country155 target enrollmentStarted: March 5, 2024Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
155
Locations
1
Primary Endpoint
Resection status

Study Overview

Brief Summary

The aim of the study is to investigate the extent to which the oncological safety of frozen sections can be improved through visual communication between head and neck surgery and pathology. To date, communication has taken place exclusively by telephone.

In the study photographs and videos of the tumor are taken and transmitted digitally to the pathology department. This provides the pathologist with a better understanding of the tumor bed and the orientation of the specimen.

Likewise, images of the frozen sections are taken in the pathology department, on which the pathologist marks margins that are not resected in sano or are only narrowly in sano. These images are transmitted to the surgeon and provide a more precise understanding of the areas where additional resection may be required.

To ensure patient safety, frozen section results are also communicated by telephone in the usual manner throughout the duration of the project.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Histological proof of malignant head and neck carcinoma by biopsy
  • Planned curative tumor resection with frozen section management

Exclusion Criteria

  • No curative tumor resection aiming for R0 status
  • Head and neck tumors not assigned to surgical treatment
  • No frozen section management planned during surgery

Arms & Interventions

Visual digital communication group

Experimental

The group receives frozen section management supported by digital visual communication between surgery and pathology during head and neck tumor resection.

Intervention: visual description of frozen section results during surgery (Procedure)

traditional telephone communication group

No Intervention

The group recieves frozen section management with conventionel communication via telephone between surgery and pathology during head and neck tumor resection

Outcomes

Primary Outcomes

Resection status

Time Frame: from day one through study completion, an average of 1 year

To increase the rate of R0 resections

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Claudia Scherl

Professor

Heidelberg University

Study Sites (1)

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