Head and Neck CarcinomaDigiComSurgNCT07378345
Optimization of Communication Between Surgery and Pathology
A study testing visual description of frozen section results during surgery in people with Head and Neck Carcinoma and Frozen Section Management, run by Heidelberg University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Carcinoma, Frozen Section Management
- What is being tested?
- visual description of frozen section results during surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteGermany
- Study dates
- 5 Mar 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological proof of malignant head and neck carcinoma by biopsy
- Planned curative tumor resection with frozen section management
Who cannot join
- No curative tumor resection aiming for R0 status
- Head and neck tumors not assigned to surgical treatment
- No frozen section management planned during surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Digitization and Optimization of Communication Between Surgery and Pathology in the Resection of Head and Neck Tumors
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.
Read more
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.
- Conditions
- Head and Neck Carcinoma, Frozen Section Management
- Being tested
- visual description of frozen section results during surgery
- Keywords
- Frozen Section, communication, Head and Neck Squamous Cell Carcinoma, Resection Status, Margin Assessment, HNSCC
- Medical subject headings
- Communication, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visual description of frozen section results during surgeryProcedure or surgery
This intervention provides more precise information on frozen section results.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resection status
To increase the rate of R0 resections
Measured: from day one through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start5 Mar 2024
- Primary completion25 Feb 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Scherl, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378345
- Sponsor's protocol ID
- 2025-01
- Acronym
- DigiComSurg
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digitization and Optimization of Communication Between Surgery and Pathology in the Resection of Head and Neck Tumors
- ClinicalTrials.gov ID
- NCT07378345
- Acronym / sponsor ID
- DigiComSurg / 2025-01
- Conditions
- Head and Neck Carcinoma, Frozen Section Management
- Keywords
- Frozen Section, communication, Head and Neck Squamous Cell Carcinoma, Resection Status, Margin Assessment, HNSCC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 25 Feb 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visual digital communication group | Experimental | Procedure: visual description of frozen section results during surgeryThe group receives frozen section management supported by digital visual communication between surgery and pathology during head and neck tumor resection. |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histological proof of malignant head and neck carcinoma by biopsy
- Planned curative tumor resection with frozen section management
Key exclusion criteria (3 listed)
- No curative tumor resection aiming for R0 status
- Head and neck tumors not assigned to surgical treatment
- No frozen section management planned during surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| visual description of frozen section results during surgeryThis intervention provides more precise information on frozen section results. | Procedure or surgery | Visual digital communication group |
Primary outcome
Resection status
Time frame: from day one through study completion, an average of 1 year
To increase the rate of R0 resections
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing visual description of frozen section results during surgery in people with Head and Neck Carcinoma and Frozen Section Management, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resection status (time frame: from day one through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.