Intraoperative Examination of Sentinel Node in Endometrial Cancer (TRSGO-SLN-003) (TRSGOSLN003)

Intraoperative Examination of Sentinel Node for The Decision of Further Lymphadenectomy in Clinical Early Stage Endometrial Cancer: A Diagnostic Study of Turkish Gynecologic Oncology Group (TRSGO-SLN-003)

More than half of the cases with macrometastatic sentinel lymph node (SLN) have non-SLN metastasis and leaving these nodes in-situ may impair the survival. This study assessed the diagnostic accuracy of intraoperative SLN frozen section examination and scrape cytology as a possible solution for management of SLN positive patients. Clinical early stage endometrial cancer patients who underwent SLN algorithm and intraoperative frozen section or scrape cytology to evaluate SLN status for metastasis were analyzed retrospectively. Intraoperative examination findings were compared with final pathology results and diagnostic accuracy of frozen section and scrape cytology were evaluated.

Study Overview

• Status: Completed
• Conditions: Endometrial Cancer; Sentinel Lymph Node
• Intervention / Treatment: Diagnostic test: Intraoperative examination of sentinel node

Detailed Description

Frozen section: Lymph nodes up to 2 mm were embedded as a whole. Lymph nodes between 2-5 mm were cut in half along their long axis and nodes larger than 5 mm were sliced in neat, parallel slices at 2-3 mm intervals-slicing was perpendicular to the long axis of the node. Then whole of the SLNs were stained with hematoxylin and eosin (H&E) and examined by frozen section.

Scrape Cytology: SLNs were cut into 3-mm-thick pieces along their long axis. If the lymph node was smaller than 3 mm, it was cut in half. Both sides of the pieces were scraped separately by an edge of a glass slide or a lancet gently. Obtained materials were smeared immediately onto a slide and placed in ethanol for fixation. Then, all slides were stained with H&E and examined.

The results were reported to the surgeon as positive (metastatic) or negative with the numbers of lymph nodes. After intraoperative examination, lymph nodes were put into formalin solution and sent for final pathologic examination.

Data analyses were performed using SPSS Version 21.0 (IBM Corporation, Armonk, NYC, USA). Shapiro-Wilk test was performed to determine whether the data were normally distributed. Descriptive statistics of continuous variables were compared between groups using Mann-Whitney U test. The Chi-square test or Fisher's exact test (when chi-square test assumptions do not hold due to low expected cell counts) were used to compare categorical variables between groups. Continuous variables were presented as median and min-max values, whereas categorical variables were presented as number and percentage. A p value of <0.05 was considered statistically significant. Performance of each protocol to predict treatment success was assessed using confidence intervals with respect to sensitivity, specificity, positive predictive value, and negative predictive value.

• Study Type: Observational
• Enrollment (Actual): 208

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06610
    • Ankara University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients with clinical early stage endometrial cancer and underwent sentinel lymph node biopsy with intraoperative examination of sentinel node by either frozen section or scrape cytology.

Description

Inclusion Criteria:

• Patients with apparently early stage endometrial cancer whose SLNs were evaluated intraoperatively were included to this study

Exclusion Criteria:

• Patients with gross metastatic disease
• Patients who had contraindications to dyes (iodine allergy or hepatic impairments)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Frozen section; Patients underwent intraoperative sentinel node examination by frozen section	Diagnostic test: Intraoperative examination of sentinel node; Intraoperative examination of sentinel node by either frozen section or scrape cytology to detect metastasis and decide for further lymphadenectomy.
Scrape cytology; Patients underwent intraoperative sentinel node examination by scrape cytology	Diagnostic test: Intraoperative examination of sentinel node; Intraoperative examination of sentinel node by either frozen section or scrape cytology to detect metastasis and decide for further lymphadenectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sensitivity for the diagnosis of metastatic lymph node intraoperatively	intraoperative test

Collaborators and Investigators

• Sponsor: Ankara University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: September 18, 2020
• First Submitted That Met QC Criteria: September 18, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): September 23, 2020
• Last Update Submitted That Met QC Criteria: September 18, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Endometrial Neoplasms
• Other Study ID Numbers: TRSGO SLN-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No