Lymph Node Yield After Specimen Fixation With Carnoy's Solution and 10% Neutral Buffered Formaldehyde in Patients With Colorectal Cancer or Gastric Adenocarcinoma Specimens: a Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 130
- Primary Endpoint
- Lymph node yield
Study Overview
Brief Summary
This study evaluates the number of lymph nodes dissected in specimens following fixation with 10% neutral buffered formaldehyde or Carnoy's solution. Specimens were randomized for fixation in each solution.
Detailed Description
Carnoy's solution is a tissue fixative that has alcohol allowing for fat clearing along with tissue fixation. Specimens were randomized after the surgical procedure. The perivisceral fat was removed from the stomach and the lymph node stations disected and then fixed in formalin or carnoy's solution for 24-48h. After dissection the residual fat from the formalin group was re-fixed in carnoy and re-disected.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Care Provider)
Masking Description
Randomization occurred after surgery, the surgeon was blind during the procedure
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Rectal Cancer:
- •Long course neoadjuvant chemoradiation
- •Low anterior resection with total mesorectal excision
- •Inclusion Criteria - Colon Cancer:
- •Rectosigmoidectomy
- •Inclusion Criteria - Gastric Cancer:
- •Gastric adenocarcinoma
- •Subtotal gastrectomy
- •D2 lymphadenectomy
Exclusion Criteria
- •Rectal Cancer:
- •Previous surgery
- •Incomplete neoadjuvant chemoradiation
- •Refuse to sign the informed consent
- •T4b and/or Multivisceral resection
- •Exclusion Criteria - Colon Cancer:
- •Previous surgery
- •Neoadjuvant chemoradiation
- •Refuse to sign the informed consent
- •T4b and/or Multivisceral resection
- •Exclusion Criteria - Gastric Cancer:
- •Distant metastasis
- •Previous upper abdomen radiotherapy
- •Previous surgery over stomach or omentum
- •Refuse to sign the informed consent
Outcomes
Primary Outcomes
Lymph node yield
Time Frame: 10 days - accessed with the pathological report for each specimen
Primary outcome will be the total number of lymph nodes dissected in each specimen
Secondary Outcomes
- Dissection duration(10 days - accessed with the pathological report for each specimen)