C44
Conditions
Interventions
Group 1: Intervention group (LC-OCT): Preoperative tumor margin assessment using LC-OCT with targeted extension of the resection margins in case of tumor detection on imaging.
Group 2: Control group (
Sponsors
Universitätsklinikum Augsburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adults (=18 years) with BCC scheduled for MMS, confirmed by dermoscopy and histopathology or OCT. There are no restrictions regarding tumor size or BCC subtypes.
Exclusion criteria
Exclusion criteria: Poor LC-OCT image quality, incomplete adherence to the protocol, prior treatment of BCC. Anatomically difficult locations for LC-OCT are to be excluded (e.g., inner ear, medial canthus of the eye).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The endpoint is the proportion of basal cell carcinomas (BCC) that were completely (R0) removed during the first surgical excision without the need for an additional MMS cycle. This is assessed on the day of surgery or the following day through histopathological examination of the initial excision specimen. This should be measured by: - the number of MMS cycles required (compared to conventional procedures), - the probability of complete tumour removal (R0) in the first incision. | — |
Secondary
| Measure | Time frame |
|---|---|
| Total duration of the surgical procedure Definition: Time in minutes from the first skin incision to the complete completion of tumor removal (last MMS cycle). Measurement time point: On the day of surgery (intraoperative). Unit: Minutes. Number of required MMS cycles Definition: Total number of excision rounds needed to ensure all tumor margins were histologically tumor-free. Measurement time point: On the day of surgery. Unit: Number (1, 2, 3, …). Size of the final skin defect Definition: Area of the surgical defect after complete tumor removal. Measurement time point: After the last excision, before wound closure. Unit: cm². Cosmetic outcome (POSAS score) Definition: Patient and Observer Scar Assessment Scale (POSAS), assessed 6–12 weeks postoperatively. Measurement time point: At follow-up visit 2 (week 6–12). Unit: Scale value (1–10 per subcategory; lower = better). Patient satisfaction Definition: Subjective evaluation of treatment by the participant (e.g., via Likert scale). Measurement time point: Week 6–12. Unit: 5- or 7-point scale. Correlation of LC-OCT margin findings with histopathological results Definition: Sensitivity, specificity, positive predictive value, and negative predictive value of LC-OCT for detecting tumor-positive margins. Measurement time point: After availability of histological results. Unit: Percent agreement. Occurrence of adverse events Definition: Any medically relevant complication related to imaging or surgery (e.g., wound infection, postoperative bleeding). Measurement time point: Until completion of the second follow-up visit. Unit: Number of events per patient group. | — |
Countries
Germany
Contacts
Public ContactJulia Welzel
Universitätsklinikum Augsburg
Outcome results
None listed