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Biopsy Incisional With Trepan in Periocular Lesions

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by University of Sao Paulo.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00865813
First received: March 18, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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


Condition Intervention
Tumor
 Procedure: Punch Biopsy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Biopsy Incisional With Trepan in Periocular Lesions

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: December 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Punch 2 mm
  • Biopsy

Detailed Description:

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00865813

Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Rachel C Carneiro University of Sao Paulo - Hospital das Clinicas
  More Information

No publications provided

Responsible Party: Suzana Matayoshi, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00865813     History of Changes
Other Study ID Numbers: 1143/07
Study First Received: March 18, 2009
Last Updated: March 18, 2009
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
Punch biopsy,
periocular
tumors.

ClinicalTrials.gov processed this record on May 22, 2013