Surgical Methods for Vulvar Dysplasia

Overseen By Maggie Dzhanumova

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two surgical methods to treat high-grade vulvar dysplasia, a condition with abnormal cells on the vulva. The researchers aim to determine if "Frozen-Section Directed Excision," a method used in skin surgery, is more effective than the current standard, "Wide Local Excision." Participants will be randomly assigned to one of these treatments to evaluate which offers better outcomes. This trial may suit individuals diagnosed with high-grade vulvar dysplasia and scheduled for surgery soon. As an unphased trial, it offers participants the chance to contribute to medical research that could enhance surgical outcomes for future patients.

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 prior data suggests that these surgical methods are safe for treating vulvar dysplasia?

Research has shown that Frozen-Section Directed Excision (FSDE) is a dependable surgical method, particularly in skin-related procedures, for accurately identifying the edges of abnormal tissue. One study found FSDE to be nearly perfect in confirming the complete removal of abnormal tissue, with an accuracy rate of 98.6%. This precision helps avoid unnecessary removal of healthy skin.

Wide Local Excision is a well-known method for treating vulvar dysplasia, involving the removal of a larger area around the abnormal tissue to ensure complete excision. This technique is usually recommended when cancer is not suspected.

Both methods are surgical procedures with some differences. FSDE, though newer for this application, shows promise in reducing residual abnormal tissue. Wide Local Excision has been used longer and is safe for non-cancerous lesions. Both methods are considered safe, but FSDE might offer more precise removal of affected tissue. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring different surgical methods for vulvar dysplasia, focusing on Frozen-Section Directed Excision and Wide Local Excision. Unlike standard treatments that often rely on visual identification and excision with broader margins, Frozen-Section Directed Excision offers a more precise approach by allowing surgeons to make smaller, 1 mm excisions around the lesion site. This could potentially lead to better outcomes by reducing the removal of healthy tissue and preserving more of the surrounding area. By comparing this method to the traditional Wide Local Excision, which uses 5 mm margins, the trial aims to find out whether more targeted excision can provide similar or better results with less impact on the patient's quality of life.

What evidence suggests that this trial's surgical methods could be effective for vulvar dysplasia?

Research has shown that Frozen-Section Directed Excision, one of the surgical methods studied in this trial, is a promising approach for treating severe vulvar dysplasia. This technique resembles Mohs Surgery, which is effective in skin treatments. Studies have demonstrated its high accuracy, with a 98.6% success rate in identifying the edges of the affected area, allowing precise removal of diseased tissue while preserving healthy tissue.

In contrast, Wide Local Excision, another method under study, is a well-known approach for this condition. It involves removing a larger area around the abnormal tissue to ensure all unhealthy cells are taken out. This method is often recommended when there is a risk of the disease spreading, as it provides effective treatment with lower chances of recurrence. Both methods are being studied for their effectiveness in managing vulvar dysplasia, offering options based on the specific needs of each case. ^{1 2 3 4 5}

Who Is on the Research Team?

Robert W Naumann, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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 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 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]

Citations

1. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/420781

A Study Evaluating the Effect of Frozen-Section Directed ... The purpose of this study is to compare "Frozen-Section Directed Excision", which has been a proven method of surgery used in dermatology, ...

2. ctv.veeva.com ctv.veeva.com/study/a-study-evaluating-the-effect-of-frozen-section-directed-excision-surgery-on-vulvar-dysplasia

A Study Evaluating the Effect of Frozen-Section Directed ... The purpose of this study is to compare "Frozen-Section Directed Excision", which has been a proven method of surgery used in dermatology, ...

3. researchgate.net researchgate.net/publication/381990409_A_prospective_randomized_single-blinded_study_evaluating_the_effect_of_frozen-section_directed_excision_on_positive_surgical_margins_in_high-grade_vulvar_dysplasia

A prospective, randomized, single-blinded study evaluating ... Our study seeks to compare this current standard of care with a frozen section directed excision, which is similar to Mohs Surgery, a long- ...

4. clinconnect.io clinconnect.io/trials/NCT05934851

A Study Evaluating the Effect of Frozen-Section Directed This clinical trial is studying a surgical technique called "Frozen-Section Directed Excision" to treat a condition known as high-grade vulvar dysplasia, which ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/20173502/

Frozen section analysis of vulvectomy specimens The accuracy rate of vulval frozen section analyses was 100% for the evaluation of Cloquet node, and 98.6% for the margin status.