Surgical Methods for Vulvar Dysplasia

Overseen By Alicia Patrick

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must not be taking: Immunosuppressants, Anticancer

Disqualifiers: Immunodeficiency, Pelvic radiation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 day

112 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare "Frozen-Section Directed Excision", which has been a proven method of surgery used in dermatology, versus the current, standard method called "Wide Local Excision" to treat high-grade vulvar dysplasia.

Will I have to stop taking my current medications?

The trial requires that you have not taken immunosuppressant medications (like those for HIV, organ transplants, or chronic steroid use) in the last 30 days. If you're on these, you may need to stop before joining.

What data supports the effectiveness of the treatment Frozen-Section Directed Excision, Mohs Micrographic Surgery, Frozen Section Technique, Wide Local Excision, Wide Local Excision, WLE for vulvar dysplasia?

Research shows that Mohs micrographic surgery is effective for removing skin cancers by precisely targeting and removing cancerous tissue while sparing healthy tissue. Wide local excision is also used effectively for early-stage vulvar melanomas, suggesting its potential usefulness in treating vulvar dysplasia. ^{1 2 3 4 5}

Is Mohs micrographic surgery safe for humans?

Mohs micrographic surgery is generally considered safe and well tolerated, with various practices in place to reduce adverse events. ^{2 4 6 7 8}

How is the treatment Frozen-Section Directed Excision, Wide Local Excision unique for vulvar dysplasia?

This treatment is unique because it uses a frozen-section technique to ensure complete removal of abnormal tissue during surgery, allowing for precise excision with minimal impact on surrounding healthy tissue. This approach is particularly beneficial for vulvar dysplasia as it helps achieve clear margins, reducing the risk of recurrence. ^{1 5 9 10 11}

Research Team

Robert W Naumann, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for adults over 18 with high-grade vulvar dysplasia who can consent, read English/Spanish, and likely have surgery within 90 days. It's not for those who've had pelvic radiation, are on immunosuppressants, or currently receiving cancer treatment.

Inclusion Criteria

Ability and willingness of the subject to comply with study procedures for the entire length of the study

Written informed consent and HIPAA authorization for release of personal health information

My surgery is scheduled within the next 3 months.

Exclusion Criteria

I have had radiation therapy in the pelvic area.

Known immunodeficiency syndrome

Surgery isn't possible for me due to the tumor's location near critical areas.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo either Frozen-Section Directed Excision or Wide Local Excision surgery

1 day

1 visit (in-person)

Recovery and Initial Follow-up

Participants are monitored for recovery, pain management, and initial wound healing

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for recurrence rates, quality of life, and sexual function

6 months

2 visits (in-person)

Treatment Details

Interventions

• Frozen-Section Directed Excision
• Wide Local Excision

Trial Overview The study compares two surgical methods for treating vulvar dysplasia: 'Frozen-Section Directed Excision' (a dermatology technique) versus the standard 'Wide Local Excision'. The goal is to see which method is more effective.

Participant Groups

Group I: Frozen-Section Directed Excision Vulvectomy Experimental Treatment 1 Intervention

The surgeon(s) will identify the lesion and make a 1 mm excision around the lesion site.

Group II: Wide Local Excision Vulvectomy Active Control 1 Intervention

The surgeon(s) will visually identify the abnormal lesion. A Wide Local Excision with 5 mm margins will be made through the dermis per standard of care.

Frozen-Section Directed Excision is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Mohs Micrographic Surgery for:

• Basal Cell Carcinoma
• Squamous Cell Carcinoma
• Melanoma
• Vulvar Dysplasia

Approved in European Union as Mohs Micrographic Surgery for:

• Basal Cell Carcinoma
• Squamous Cell Carcinoma
• Melanoma

Approved in Canada as Frozen Section Technique for:

• Basal Cell Carcinoma
• Squamous Cell Carcinoma

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Atrium Health Levine Cancer Institute

Collaborator

Trials

30

Recruited

4,700+

Findings from Research

Wide local excision was successfully performed on three patients with early-stage vulvar melanoma, with no evidence of recurrence during long-term follow-up.

The study suggests that wide local excision with adequate tumor-free margins is an effective treatment option for early-stage vulvar melanomas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conservative surgical treatment for early-stage vulvar malignant melanoma. Nasu, K., Kai, Y., Ohishi, M., et al.[2009]

The new mould and glass disc technique for Mohs surgery significantly reduces the number of frozen sections needed to achieve a complete macroscopic cross-section of skin specimens, requiring only 10.6 sections compared to 90.1 sections with the modern method.

This new approach not only improves the efficiency of the procedure but also enhances the quality of histologic slides and reduces the number of deeper levels needed for adequate microscopic evaluation, demonstrating its potential as a superior method for treating aggressive skin cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mohs surgery - a new approach with a mould and glass discs: review of the literature and comparative study. Gauthier, P., Ngo, H., Azar, K., et al.[2019]

A study involving 1,720 cases over 10 years found a remarkable 99.5% concordance rate in frozen section slide interpretations between fellowship-trained Mohs surgeons and dermatopathologists.

This high level of agreement highlights the reliability of frozen section analysis in Mohs micrographic surgery, which is crucial for effective tumor removal while preserving healthy tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Histologic Accuracy of Mohs Micrographic Surgery. Highsmith, JT., Highsmith, MJ., Monheit, GD.[2018]

Mohs micrographic surgery is a highly effective method for removing certain skin cancers, focusing on excising tumors with minimal damage to surrounding healthy tissue.

This technique allows for immediate examination of the excised tissue, ensuring complete removal of the cancerous cells, especially in cases of aggressive or recurrent tumors located in sensitive areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A primer of Mohs micrographic surgery: common indications. Nouri, K., Rivas, MP.[2019]

In a study of 537 women undergoing vulvar surgery for premalignant lesions, 28.7% experienced wound complications, with smoking and primary surgery being significant risk factors for these complications.

Preoperative antibiotic prophylaxis did not significantly reduce the overall rate of wound complications, although it was associated with a shorter mean length of wound separation, suggesting a potential benefit that needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wound Complication Rates After Vulvar Excisions for Premalignant Lesions. Mullen, MM., Merfeld, EC., Palisoul, ML., et al.[2021]

In a study analyzing 150 cases of skin lesions, primarily basal cell and squamous cell carcinomas, the accuracy of frozen section analysis was found to be 97.7% when compared to formal paraffin sections, indicating its high reliability in surgical settings.

Despite the high accuracy, the study noted a 14.8% incomplete resection rate, particularly in cases with known positive margins, suggesting that while frozen sections are effective, careful consideration is needed in their interpretation and subsequent surgical decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of frozen section in the excision of cutaneous malignancy: a Queensland experience. Castley, AJ., Theile, DR., Lambie, D.[2022]

A survey of 177 dermatologic surgeons revealed that 96% prescribe systemic antibiotics preoperatively and 91% postoperatively, indicating a strong reliance on antibiotic prophylaxis to prevent infections during Mohs micrographic surgery.

The study highlighted significant variability in perioperative practices, such as the management of anticoagulant medications and antiseptic choices, suggesting a need for standardized guidelines to improve patient safety and outcomes in dermatologic surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative Practices in Dermatologic Surgery. Erickson, SP., Schneider, SL., Cohen, JL., et al.[2022]

The study analyzed 284 tissue blocks and found that complete sections in Mohs micrographic surgery (MMS) were typically achieved at a depth of 285 μm, with variations based on tissue size and location.

The methodology used in this research demonstrated significant differences in sectioning techniques among histotechnicians, highlighting the importance of precise tissue sectioning to maintain the high cure rates and tissue preservation that MMS is known for.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative Analysis of Frozen Section Histology in Mohs Micrographic Surgery. LeBoeuf, M., Bieber, K., Cooper, S., et al.[2021]

In a 5-year study analyzing 7,921 frozen section evaluations, vulvar cancer specimens accounted for 10.6%, with a 100% accuracy rate for assessing Cloquet nodes and 98.6% for resection margin status.

The average time for frozen section analysis of vulvectomy specimens was 24.5 minutes, suggesting that standardized procedures for handling these specimens could enhance surgical outcomes in vulvar cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frozen section analysis of vulvectomy specimens: results of a 5-year study period. Horn, LC., Wagner, S.[2010]

A careful diagnostic excision of vulvar carcinoma is essential for determining histologic prognosis factors, which guides the planning of subsequent surgical procedures.

Various safe plastic reconstructive methods have been developed to effectively address surgical defects, ensuring both functional and cosmetic outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Indications and results of reconstructive surgery of the vulva]. Weikel, W., Knapstein, PG.[2008]

In a study of 50 patients with stage I squamous cell carcinoma of the vulva, wide local excision combined with superficial inguinal lymphadenectomy showed promising results, with only one patient dying from recurrent cancer 16 months post-surgery.

The surgical approach resulted in significantly lower morbidity compared to more extensive surgeries typically used for vulvar cancer, making it a recommended option for managing early invasive disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conservative surgical management of superficially invasive stage I vulvar carcinoma. Berman, ML., Soper, JT., Creasman, WT., et al.[2019]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Conservative surgical treatment for early-stage vulvar malignant melanoma. [2009]

2. Canada pubmed.ncbi.nlm.nih.gov

Mohs surgery - a new approach with a mould and glass discs: review of the literature and comparative study. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Histologic Accuracy of Mohs Micrographic Surgery. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

A primer of Mohs micrographic surgery: common indications. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Wound Complication Rates After Vulvar Excisions for Premalignant Lesions. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

The use of frozen section in the excision of cutaneous malignancy: a Queensland experience. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Perioperative Practices in Dermatologic Surgery. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Quantitative Analysis of Frozen Section Histology in Mohs Micrographic Surgery. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Frozen section analysis of vulvectomy specimens: results of a 5-year study period. [2010]

10. Germany pubmed.ncbi.nlm.nih.gov

[Indications and results of reconstructive surgery of the vulva]. [2008]

11. United States pubmed.ncbi.nlm.nih.gov

Conservative surgical management of superficially invasive stage I vulvar carcinoma. [2019]