Prospective Randomized Trial: Curettage Versus Excision in Nodular and Superficial Basal Cell Carcinomas - Full Text View

Sponsored by:	University Hospital Tuebingen
Information provided by:	University Hospital Tuebingen
ClinicalTrials.gov Identifier:	NCT00515970

Purpose

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.

Condition	Intervention
Carcinoma, Basal Cell	Procedure: Curettage Procedure: Deep excision Procedure: Shave excision

MedlinePlus related topics: Cancer Scars

Drug Information available for: Paraffin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Prospective Randomized Trial: Curettage Versus Excision in Nodular and Superficial Basal Cell Carcinomas

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:

Recurrence of BCC, confirmed by biopsy [ Time Frame: 4 years after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Secondary hemorrhage as remembered by the patient [ Time Frame: 3 months (plus or minus 30 days) after surgery ] [ Designated as safety issue: Yes ]
Wound infection as remembered by the patient [ Time Frame: 3 months (plus or minus 30 days) after surgery ] [ Designated as safety issue: Yes ]
Hypesthesia after surgery [ Time Frame: 3 months (plus or minus 30 days) after surgery ] [ Designated as safety issue: No ]
Keloid [ Time Frame: 3 months (plus or minus 30 days) after surgery ] [ Designated as safety issue: No ]
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. [ Time Frame: 3 months (plus or minus 30 days) after surgery ] [ Designated as safety issue: No ]
Subjective assessment of the esthetic outcome of the scar on a scale of excellent, good, satisfying, moderate, unfavorable; done by the patient [ Time Frame: 3, 6, 12, 24, 36, and 48 months (plus or minus 30 days) after surgery ] [ Designated as safety issue: No ]
Subjective assessment of the esthetic outcome of the scar on a scale of excellent, good, satisfying, moderate, unfavorable; done by the study physician [ Time Frame: 3, 6, 12, and 48 months (plus or minus 30 days) after surgery ] [ Designated as safety issue: No ]
Subjective assessment of the esthetic outcome of the scar on a scale of excellent, good, satisfying, moderate, unfavorable; done by a private practitioner [ Time Frame: 12, 24, and 36 months (plus or minus 30 days) after surgery ] [ Designated as safety issue: No ]
Scar length in mm [ Time Frame: 6 and 48 months (plus or minus 30 days) after surgery ] [ Designated as safety issue: No ]
Scar width in mm, perpendicular to its length [ Time Frame: 6 and 48 months (plus or minus 30 days) after surgery ] [ Designated as safety issue: No ]
Color of the scar: hyperpigmented, hypopigmented, or erythematous [ Time Frame: 6 and 48 months (plus or minus 30 days) after surgery ] [ Designated as safety issue: No ]
Level of the scar: atrophic, skin level, hypertrophic, or keloid [ Time Frame: 6 and 48 months (plus or minus 30 days) after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Clinical or histologic diagnosis of nodular BCC	Procedure: Curettage 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.
2: Active Comparator Clinical or histologic diagnosis of nodular BCC	Procedure: Deep excision 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.
3: Experimental Clinical or histologic diagnosis of superficial BCC	Procedure: Curettage Curettage with a 7 mm ring curette with the "potato-peeler technique" (http://www.biopsypunch.com/kuerettagetechnik.htm; accessed on March 13, 2008). The handle of the curette is held in the distal inter-digital fold of the index finger, and supported by the other fingers of the curetting hand. The thumbs serve to provide a stable base. This technique makes it possible to guide the instrument, applying greater pressure, but accuracy is reduced. 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.
4: Active Comparator Clinical or histologic diagnosis of superficial BCC	Procedure: Shave excision 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.

Show Detailed Description

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical or histologic diagnosis of BCC

Patient Dependent Exclusion Criteria:

> 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

Tumor Exclusion Criteria:

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
Histopathologic evidence of a tumor type different from nodular or superficial BCC

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00515970

Contacts

Contact: Helmut Breuninger, M.D.	+49-70 71-29 ext 8 45 90	helmut.breuninger@med.uni-tuebingen.de
Contact: Kay D Brantsch, M.D.	+49-1 72 ext 3 77 58 53	Kay.Brantsch@med.uni-tuebingen.de

Locations

Germany, Baden-Wuerttemberg
Department of Dermatology, Eberhard Karls University	Recruiting
Tuebingen, Baden-Wuerttemberg, Germany, 72076

Sponsors and Collaborators

University Hospital Tuebingen

Investigators

Study Chair:	Helmut Breuninger, M.D.	Department of Dermatology, Eberhard Karls University Tuebingen
Principal Investigator:	Kay D Brantsch, M.D.	Department of Dermatology, Eberhard Karls University Tuebingen

More Information

Responsible Party:	Eberhard Karls University Tuebingen, Medical School ( Bettina Faust )
Study ID Numbers:	E.03.26007.1
Study First Received:	August 13, 2007
Last Updated:	March 14, 2008
ClinicalTrials.gov Identifier:	NCT00515970
Health Authority:	Germany: Federal Ministry of Education and Research

Keywords provided by University Hospital Tuebingen:

Carcinoma, Basal Cell
Curettage
Excision

Recurrence
Complication
Esthetic outcome

Study placed in the following topic categories:

Carcinoma, Basal Cell
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Basal Cell

ClinicalTrials.gov processed this record on January 16, 2009