Biopsy Incisional With Trepan in Periocular Lesions

March 18, 2009 updated by: University of Sao Paulo
The purpose of this study was to identify accuracy rates of 2mm punch biopsy technique in diagnosing periocular malignancy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Punch Biopsy
Procedure: Punch Biopsy
  1. Instillation of anesthetic eye drops.
  2. Asepsis
  3. Placement of surgical cloths and drapes
  4. Infiltration of the involved region with anesthetic solution plus adrenalin in1:200.00 dilution.
  5. 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
  6. 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
Other Names:
  • Biopsy
  • Punch 2 mm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
accuracy, positive predictive value, negative predictive value, sensitivity, specificity
Time Frame: In each case, the histology obtained at biopsy was compared with that identified at the time of tumor excision.
In each case, the histology obtained at biopsy was compared with that identified at the time of tumor excision.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Rachel C Carneiro, University of Sao Paulo - Hospital das Clinicas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Anticipated)

October 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

March 18, 2009

First Submitted That Met QC Criteria

March 18, 2009

First Posted (Estimate)

March 19, 2009

Study Record Updates

Last Update Posted (Estimate)

March 19, 2009

Last Update Submitted That Met QC Criteria

March 18, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1143/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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