NCT07378345

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

12 months

First QC Date

January 14, 2026

Last Update Submit

January 26, 2026

Conditions

Keywords

Frozen SectioncommunicationHead and Neck Squamous Cell CarcinomaResection StatusMargin AssessmentHNSCC

Outcome Measures

Primary Outcomes (1)

  • Resection status

    To increase the rate of R0 resections

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

Study Arms (2)

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.

Procedure: visual description of frozen section results during surgery

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

Interventions

This intervention provides more precise information on frozen section results.

Visual digital communication group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universtiy of Heidelberg

Mannheim, Germany

Location

MeSH Terms

Conditions

CommunicationSquamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

BehaviorCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 14, 2026

First Posted

January 30, 2026

Study Start

March 5, 2024

Primary Completion

February 25, 2025

Study Completion

December 31, 2025

Last Updated

January 30, 2026

Record last verified: 2026-01

Locations