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A Randomized Clinical Trial in the Surgical Treatment of Basal Cell Carcinoma of the Eyelid: Surgical Excision With Frozen Section vs. Permanent Section Control

Phase 3
18 Years
Open (Enrolling)
Basal Cell Carcinoma

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Trial Information

A Randomized Clinical Trial in the Surgical Treatment of Basal Cell Carcinoma of the Eyelid: Surgical Excision With Frozen Section vs. Permanent Section Control

Basal cell carcinoma (BCC) accounts for 80-90% of skin cancers and is the most common skin
cancer of the periocular region. Surgical excision is considered the gold-standard in
therapy. Previous literature has shown comparable recurrence rates of BCC between surgical
excision with frozen section control and surgical excision and permanent section control. To
data, there are no prospective studies comparing frozen section control with permanent
section control. We hypothesize that short term tumor clearance rates between frozen section
and permanent section control will be similar and that long-term tumor recurrence rates will
be similar between the two techniques. If we find that these two treatment options are
equivalent with respect to margin control and recurrence rates, then considerable time and
money savings can be accrued through using permanent section control amongst patients with
periocular BCC.

The study design is a single-blind randomized controlled trial. Patients who have already
agreed to surgical excision of nodular type periocular BCC will be eligible. All patients
will undergo a detailed informed consent process. All patients will undergo a punch biopsy
to confirm the histopathological diagnosis of BCC. The study design will be a
single-blinded, randomized clinical trial. Statistically, the study will be designed as an
equivalency study. Prior to randomization the BCC will be excised with 3mm clinical margins
in a standard fashion. Subjects will then be randomized to one of two groups: 1. Frozen
section control; 2. Permanent section control. For those patients randomized to permanent
section control the clinical sample will be sent for pathologic analysis and surgical
reconstruction will be performed immediately using standard oculoplastic techniques.
Patients randomized to frozen section will have additional margins re-excised if necessary
depending on the pathologic results. Oculoplastic reconstruction will be performed after all
margins are clear. Patients will undergo examinations at the following times to assess for
clinical recurrence: 1. 2 weeks and as necessary thereafter to assess surgical result and
wound healing, 2. 6 months, 3. 1 year, 4. yearly up to 5 years.

Inclusion Criteria:

- 18 years old or greater

- Diagnosed with clinically nodular BCC in the periocular region confirmed by tissue

- Agreeable and medically able to undergo surgical excision of the BCC

- Able to give informed consent and consent has been signed

- Able to return for all follow up visits

Exclusion Criteria:

- BCC greater than 2cm in diameter (based on clinical examination)

- Patient with a medical condition predisposing to multiple BCC's (ex. basal cell nevus

- Recurrent BCC's (i.e. a BCC that has been treated previously by surgical or other
modality and has recurred will not be eligible)

- Clinically aggressive morpheaform subtype of BCC

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:

The proportion of BCC's that are pathologically clear of tumor cells in the permanent section group compared with the frozen section group (presumably clear for all patients).

Outcome Time Frame:

1.5 years

Safety Issue:


Principal Investigator

Vladimir Kratky, MD, FRCSC

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Ophthalmology, Queen's University, Kingston, ON


Canada: Canadian Institutes of Health Research

Study ID:




Start Date:

August 2008

Completion Date:

June 2013

Related Keywords:

  • Basal Cell Carcinoma
  • Basal Cell Carcinoma
  • BCC
  • Periocular BCC
  • Frozen Section Control
  • Permanent Section Control
  • Recurrence Rates
  • Carcinoma
  • Carcinoma, Basal Cell