Sentinel Lymph Node Biopsy Versus Lymphadenectomy in Endometrial Cancer

Sponsor

Far Eastern Memorial Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05048173

Collaborator

(none)

400

Enrollment

Location

Anticipated Duration (Months)

33.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Early Stage Endometrial Cancer Sentinel Lymph Nodes Lymphadenectomy	Procedure: Sentinel lymph node mapping and biopsy Procedure: Lymphadenectomy

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 Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital	Banqiao	New Taipei	Taiwan	22050

Sponsors and Collaborators

Far Eastern Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sheng-Mou Hsiao, Chief of Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital

ClinicalTrials.gov Identifier:

NCT05048173

Other Study ID Numbers:

110187-E

First Posted:

Sep 17, 2021

Last Update Posted:

Feb 8, 2022

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Endometrial Neoplasms

Study Results

No Results Posted as of Feb 8, 2022