MedTrace Logo

Lymphadenectomy in Early Ovarian Cancer

NCT04710797 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 656

Last updated 2021-01-15

No results posted yet for this study

Summary

To assess the impact of comprehensive staging surgery with no lymphadenectomy on survival and quality of life in patients with early-stage ovarian cancer.

Conditions

Interventions

PROCEDURE

Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy

* open or minimally invasive surgical approach * cytologic examinations * All peritoneal surfaces should be visualized, and any peritoneal suspicious for metastasis should be selectively excised or biopsied * BSO and hysterectomy * For selected patients desiring to preserve fertility, USO or BSO with uterine preservation may be considered * Omentectomy * Para-aortic lymph node dissection should be performed by stripping the nodal tissue from the vena cava and the aorta bilaterally to at least the level of the inferior mesenteric artery and preferably to the level of the renal vessels * The preferred method of dissecting pelvic lymph nodes is bilateral removal of lymph nodes overlying and anterolateral to the common iliac vessel, overlying and medial to the external iliac vessel, overlying and medial to the hypogastric vessels, and from the obturator fossa at a minimum anterior to the obturator nerve

PROCEDURE

Comprehensive staging surgery with no Lymphadenectomy

* open or minimally invasive surgical approach * cytologic examinations * All peritoneal surfaces should be visualized, and any peritoneal suspicious for metastasis should be selectively excised or biopsied * BSO and hysterectomy * For selected patients desiring to preserve fertility, USO or BSO with uterine preservation may be considered * Omentectomy * In open approach surgery, exploring the pelvic and Para-aortic lymph node with hand. In minimally invasive surgery, the peritoneal above the pelvic and Para-aortic lymph node area should be open and visualized.Biopsy and frozen section of the suspicious lymph nodes

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Jihong Liu, Ph.D. · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-31
Primary Completion
2025-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04710797 on ClinicalTrials.gov