Sentinel Lymph Node Biopsy Versus Lymphadenectomy in Endometrial Cancer

NCT05048173 | Completed DMC

• 1 other identifier: 110187-E
• Study Type: observational
• Target: 334
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Early Stage Endometrial Cancer; Sentinel Lymph Nodes; Lymphadenectomy

Outcome Measures

Primary Outcomes (2)

• progression free survival

  The length of time from the day of operation till recurrence or last follow up

  4 years

• overall survival

  The length of time from the day of operation till death (of any cause) or last follow up

  4 years

Secondary Outcomes (1)

• surgical complications related to lymph node biopsy or lymphadenectomy

  from the day of operation till post-operative 6 months

Study Arms (2)

Sentinel lymph node group

woman who had sentinel lymph node mapping and biopsy

Procedure: Sentinel lymph node mapping and biopsy

Lymphadenectomy group

woman who underwent traditional pelvic lymphadenectomy without sentinel lymph node mapping

Procedure: Lymphadenectomy

Interventions

Sentinel lymph node mapping and biopsy PROCEDURE

Sentinel lymph node mapping with indocyanine green dye followed by biopsy if positive

Sentinel lymph node group

Lymphadenectomy PROCEDURE

Conventional lymphadenectomy

Lymphadenectomy group

Eligibility Criteria

• Age: 20 Years+
• Gender Eligibility Details: early stage endometrial cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

Location

MeSH Terms

Interventions

Biopsy; Lymph Node Excision

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Department of Obstetrics & Gynecology

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: September 17, 2021
• Study Start: October 1, 2021
• Primary Completion: June 2, 2022
• Study Completion: June 2, 2022
• Last Updated: September 15, 2023

Record last verified: 2023-09

Locations

TW (1)