Sentinel Lymph Nodes Biopsy in Cervical Cancer

NCT06169787 — Unknown, 70 participants, Far Eastern Memorial Hospital

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Sentinel Lymph Nodes Biopsy Versus Lymphadenectomy in Cervical Cancer

Registry	NCT06169787
Status	Unknown
Study type	Observational
Enrollment	70 (Estimated)
Sponsor	Far Eastern Memorial Hospital (Other)
Conditions	Sentinel Lymph Node
Interventions	sentinel lymph node biopsy, comprehensive pelvic lymphadenectomy (Procedure)
Dates	start 2023-10-14, primary completion 2024-08-31 (estimated), completion 2024-09-30 (estimated), first posted 2023-12-14, last updated 2024-06-17
Locations	1 site in Taiwan

-Summary

This study aims to compare sentinel lymph nodes biopsy versus comprehensive lymphadenectomy in patients with early stage cervical cancer who underwent radical hysterectomy.

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+Arms and interventions

Arm	Type	Interventions	Description
Sentinel Lymph Node		Procedure: sentinel lymph node biopsy	Sentinel lymph node biopsy in patients with early stage cervical cancer
Lymphadenectomy		Procedure: comprehensive pelvic lymphadenectomy	Comprehensive lymphadenectomy in patients with early stage cervical cancer

sentinel lymph node biopsy (Procedure): sentinel lymph node biopsy
comprehensive pelvic lymphadenectomy (Procedure): comprehensive pelvic lymphadenectomy

+Outcome measures

Primary outcomes

progression free survival [5 years]: progression free survival between these two groups

Secondary outcomes

overall survival [5 years]: overall survival between these two groups
Number of dissected lymph node [5 years]: Number of dissected lymph node between these two groups

Other outcomes

Complications [5 years]: Compication rates between the traditional and sentinel lymph node dissection groups

+Eligibility

Sex: Female, ages: 20 Years to any

Inclusion Criteria:

Women aged 20 and above with clinical FIGO stage I-IIA cervical cancer

Exclusion Criteria:

Women did not receive surgical treatment

+Locations (1)

Facility	City	Country	Status
Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital	Banqiao District, New Taipei	Taiwan