Curettage Versus Excision in Nodular and Superficial Basal Cell Carcinomas

NCT00515970 | Suspended DMC

• 1 other identifier: E.03.26007.1
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Basal cell carcinoma (BCC) is the most frequent skin cancer. Uncontrolled growth destroys local anatomic structures. There are various treatment alternatives with different recurrence rates and expenses. After surgical excision, the recurrence rate is in between 3 and 4% and the procedure is relatively expensive. Photodynamic therapy as well as imiquimod 5% are expensive therapies with high recurrence rates, that lack histologic evidence of BCC. Cryosurgery and curettage are inexpensive, although the recurrence rates are higher than after surgical excision. This prospective, randomized trial compares recurrence rates, cosmetic outcome, and surgery-related complications after curettage versus surgical excision in nodular and superficial BCC. About 600 tumors will be included. One half is treated by curettage, the other half by surgical excision. The follow-up period is four years. If the difference between recurrence rates is ≤7% and the cosmetic outcome as well as the surgery-related complications are not worse after curettage, surgical excision must be considered an overtreatment.

Conditions

Carcinoma, Basal Cell

Keywords

Carcinoma, Basal Cell; Curettage; Excision; Recurrence; Complication; Esthetic outcome

Outcome Measures

Primary Outcomes (1)

• Recurrence of BCC, confirmed by biopsy

  4 years after surgery

Secondary Outcomes (12)

• Secondary hemorrhage as remembered by the patient

  3 months (plus or minus 30 days) after surgery

• Wound infection as remembered by the patient

  3 months (plus or minus 30 days) after surgery

• Hypesthesia after surgery

  3 months (plus or minus 30 days) after surgery

• Keloid

  3 months (plus or minus 30 days) after surgery

• Functional impairment or disfigurement by the scar. Keloid is always a disfiguring scar. If the scar is recognized as keloid, the measure "disfigurement" cannot be used here.

  3 months (plus or minus 30 days) after surgery

Study Arms (4)

1

EXPERIMENTAL

Clinical or histologic diagnosis of nodular BCC

Procedure: Curettage

2

ACTIVE COMPARATOR

Clinical or histologic diagnosis of nodular BCC

Procedure: Deep excision

3

EXPERIMENTAL

Clinical or histologic diagnosis of superficial BCC

Procedure: Curettage

4

ACTIVE COMPARATOR

Clinical or histologic diagnosis of superficial BCC

Procedure: Shave excision

Interventions

Curettage PROCEDURE

Curettage without subcutaneous tissue using a 7 mm ring curette and the "fountain-pen technique" (http://www.biopsypunch.com/kuerettagetechnik.htm; accessed on March 13, 2008). The curette is held between the thumb, index and middle finger. This method of holding enables precise guiding of the instrument, so that the piece of tissue can be removed in one well-targeted incision. After macroscopically complete removal, a safety margin is removed with the curette. It is used for histology to distinguish between R0 (excision margin without tumor cells) and R1 resection (excision margin containing tumor cells). Preparation with paraffin. Parallel, vertical sections for histologic diagnosis. Hematoxylin-eosin staining. Measurement of tumor thickness in mm.

1

Deep excision PROCEDURE

12 o'clock mark. Excision with a scalpel down to the subcutaneous level. Plastic reconstruction. Three vertical, parallel bread loaf sections for histology. Preparation with paraffin. Staining with hematoxylin-eosin. Histologic diagnosis including report of tumor thickness in mm. Comment on complete removal (R0 versus R1). In case of R1 excision directed reoperations are performed until R0 is achieved.

2

Shave excision PROCEDURE

Shave excision with a safety margin, using a scalpel. Wound healing by secondary intention. Preparation with paraffin. Parallel vertical bread loaf sections for histology. Staining with hematoxylin-eosin. Histologic diagnosis. Comment on complete removal (R0 versus R1). In case of R1 excision a reoperation is performed until R0 is achieved.

4

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical or histologic diagnosis of BCC

You may not qualify if:

• \> 5 BCCs at presentation
• Immunosuppressive drugs
• Pregnancy
• Disability to give informed consent
• Synchronous participation in other studies
• Progeroid syndromes
• Other malignant tumors, except for BCC and squamous cell carcinoma, or monoclonal neoplasms of the hematopoietic or immune system
• Critical illness precluding sufficient follow-up visits
• Recurrent BCC
• Nodular BCC with an exophytic part of \> 1.5 mm above skin level
• Nodular BCC with a diameter of \> 10 mm
• Superficial BCC with a diameter of \> 20 mm
• Ulceration
• Scarring
• Blurred margins

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

Department of Dermatology, Eberhard Karls University

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell; Recurrence

Interventions

Curettage

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Helmut Breuninger, M.D.

  Department of Dermatology, Eberhard Karls University Tuebingen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 13, 2007
• First Posted: August 14, 2007
• Study Start: December 1, 2007
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 15, 2010

Record last verified: 2010-06

Locations

DE (1)