Sentinel Lymph Node Biopsy Versus Lymphadenectomy in Endometrial Cancer

Completed

• Conditions: Lymphadenectomy; Sentinel Lymph Nodes; Early Stage Endometrial Cancer
• Interventions: Procedure: Sentinel lymph node mapping and biopsy; Procedure: Lymphadenectomy

• Registration Number: NCT05048173
• Lead Sponsor: Far Eastern Memorial Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-12-18
• Study First Submitted QC: 2021-09-16
• Study First Posted: 2021-09-17
• Study Start: 2021-10-01
• Primary Completion: 2022-06-02
• Study Completion: 2022-06-02
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-14
• Last Update Posted: 2023-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 334

Inclusion Criteria

• ≧ 20 years
• early stage endometrial cancer (FIGO stage I)

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital; 🇨🇳 Banqiao, New Taipei, Taiwan