Biopsy Incisional With Trepan in Periocular Lesions

Tumor Clinical Trial

Official title:

Biopsy Incisional With Trepan in Periocular Lesions

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00865813
• Other study ID #: 1143/07
• Status: Active, not recruiting
• Phase: N/A
• First received: March 18, 2009
• Last updated: March 18, 2009
• Start date: December 2008
• Est. completion date: December 2009

Study information

• Verified date: March 2009
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to identify accuracy rates of 2mm punch biopsy technique in diagnosing periocular malignancy.

Description:

In each case, the histology obtained at biopsy was compared with that identified at the time of tumor excision.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All lesions were initially examined at the slitlamp, after which lesions with malignant characteristics such as texture, size or color alterations asociated with ulceration, prominent borders or elevated contours, irregular borders, telangiectasias or loss of eyelashes were included.

Exclusion Criteria:

• Lesions with not malignant characteristics

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Tumor

Intervention

Procedure:
• Punch Biopsy
Instillation of anesthetic eye drops. Asepsis Placement of surgical cloths and drapes Infiltration of the involved region with anesthetic solution plus adrenalin in1:200.00 dilution. Trephination of the most typical area of the lesion with a punch (2mm in diameter) of stainless steel by applying gentle pressure and twisting the trephine until its introduction into the suspicious lesions Removal of the excised tissue with the aid of an insulin needle or conjuntival forceps, the base then bein cut with an number 11 surgical blade

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	accuracy, positive predictive value, negative predictive value, sensitivity, specificity		In each case, the histology obtained at biopsy was compared with that identified at the time of tumor excision.	Yes