Sentinel Lymph Node Biopsy Versus Lymphadenectomy in Endometrial Cancer

Lymphadenectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05048173
• Other study ID #: 110187-E
• Status: Completed
• Start date: October 1, 2021
• Est. completion date: June 2, 2022

Study information

• Verified date: September 2023
• Source: Far Eastern Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: June 2, 2022
• Est. primary completion date: June 2, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Early Stage Endometrial Cancer
• Endometrial Neoplasms
• Lymphadenectomy

Intervention

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

Locations

Country	Name	City	State
Taiwan	Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital	Banqiao	New Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival	The length of time from the day of operation till recurrence or last follow up	4 years
Primary	overall survival	The length of time from the day of operation till death (of any cause) or last follow up	4 years
Secondary	surgical complications related to lymph node biopsy or lymphadenectomy	asymptomatic lymphocele, lymphedema, infected lymphocele	from the day of operation till post-operative 6 months