Sentinel Lymph Node Biopsy Versus Lymphadenectomy in Endometrial Cancer

Overview

To compare sentinel lymph nodes biopsy versus comprehensive lymphadenectomy in patients with early stage endometrial cancer.

Full Title of Study: “Sentinel Lymph Node Biopsy Versus Pelvic Lymphadenectomy in Early Stage Endometrial Cancer”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: September 30, 2022

Detailed Description

This retrospective study aims to compare sentinel lymph nodes biopsy versus comprehensive lymphadenectomy in patients with early stage endometrial cancer by reviewing the medical records.

Interventions

  • Procedure: Sentinel lymph node mapping and biopsy
    • Sentinel lymph node mapping with indocyanine green dye followed by biopsy if positive
  • Procedure: Lymphadenectomy
    • Conventional lymphadenectomy

Arms, Groups and Cohorts

  • Sentinel lymph node group
    • woman who had sentinel lymph node mapping and biopsy
  • Lymphadenectomy group
    • woman who underwent traditional pelvic lymphadenectomy without sentinel lymph node mapping

Clinical Trial Outcome Measures

Primary Measures

  • progression free survival
    • Time Frame: 4 years
    • The length of time from the day of operation till recurrence or last follow up
  • overall survival
    • Time Frame: 4 years
    • The length of time from the day of operation till death (of any cause) or last follow up

Secondary Measures

  • surgical complications related to lymph node biopsy or lymphadenectomy
    • Time Frame: from the day of operation till post-operative 6 months
    • asymptomatic lymphocele, lymphedema, infected lymphocele

Participating in This Clinical Trial

Inclusion Criteria

  • ≧ 20 years – early stage endometrial cancer (FIGO stage I) Exclusion Criteria:

  • Did not receive a complete course of treatment in this hospital, interrupted the treatment halfway (except if the disease continued to deteriorate or caused death during treatment), and did not follow up in this hospital after the course of treatment.

Gender Eligibility: Female

early stage endometrial cancer

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Far Eastern Memorial Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sheng-Mou Hsiao, Chief of Department of Obstetrics & Gynecology – Far Eastern Memorial Hospital
  • Overall Contact(s)
    • Sheng-Mou Hsiao, MD, +886919302632, smhsiao2@gmail.com

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