Sentinel Lymph Node Biopsy Versus Lymphadenectomy in Endometrial Cancer

September 14, 2023 updated by: Sheng-Mou Hsiao, Far Eastern Memorial Hospital

Sentinel Lymph Node Biopsy Versus Pelvic Lymphadenectomy in Early Stage Endometrial Cancer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

334

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • New Taipei
      • Banqiao, New Taipei, Taiwan, 22050
        • Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women aged 20 and above, diagnosed with early stage endometrial cancer (FIGO stage I), who had received staging surgery between 01 July 2017 and 19 August 2021 were included in the study.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sentinel lymph node group
woman who had sentinel lymph node mapping and biopsy
Procedure: Sentinel lymph node mapping and biopsy
Sentinel lymph node mapping with indocyanine green dye followed by biopsy if positive
Lymphadenectomy group
woman who underwent traditional pelvic lymphadenectomy without sentinel lymph node mapping
Procedure: Lymphadenectomy
Conventional lymphadenectomy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from the day of operation till post-operative 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Far Eastern Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

June 2, 2022

Study Completion (Actual)

June 2, 2022

Study Registration Dates

First Submitted

December 18, 2020

First Submitted That Met QC Criteria

September 16, 2021

First Posted (Actual)

September 17, 2021

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 14, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 110187-E

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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