STELLA Trial: Staging of Endometrial and Ovarian Cancer Comparing the Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Lymphadenectomy of Aortic Nodes
N/A
N/A
Female
Endometrial Neoplasms, Ovarian Neoplasms
Trial Information
STELLA Trial: Staging of Endometrial and Ovarian Cancer Comparing the Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Lymphadenectomy of Aortic Nodes
Inclusion Criteria:
- Diagnosis of endometrial cancer confirmed by histopathological analysis (endometrial
biopsy) requiring surgical staging according to FIGO (the International Federation of
Gynecology and Obstetrics) recommendations
- Diagnosis of ovarian cancer confirmed by histopathological analysis after an initial
cystectomy or oophorectomy without suspicion of neoplasia thus requiring additional
surgical staging according to FIGO recommendations
Exclusion Criteria:
- Diagnosis of advanced endometrial cancer based on findings on imaging techniques (CT,
MRI and/or PET)
- Diagnosis of advanced endometrial or ovarian cancer based on intraoperative findings
(e.g. peritoneal carcinomatosis at initial laparoscopy)
- Patients who underwent previous aortic lymphadenectomy
- Patients who received previous pelvic and/or aortic radiotherapy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)
Outcome Measure:
Number of lymph nodes
Outcome Description:
The number of lymph nodes (absolute number) is specified by the pathologist on histopathological analysis of the sample sent by the surgeon after surgical staging is realized (laparoscopic aortic lymphadenectomy). This variable is subdivided into: supra-mesenteric and infra-mesenteric.
Outcome Time Frame:
After aortic lymphadenectomy is completed
Safety Issue:
No
Principal Investigator
Antonio Gil Moreno, M.D., PhD
Investigator Role:
Study Director
Investigator Affiliation:
Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
Authority:
Spain: Ethics Committee
Study ID:
STELLA
NCT ID:
NCT01810874
Start Date:
June 2012
Completion Date:
Related Keywords:
- Endometrial Neoplasms
- Ovarian Neoplasms
- extraperitoneal
- transperitoneal
- laparoscopic aortic lymphadenectomy
- endometrial ovarian cancer
- ovarian cancer
- surgical staging
- Neoplasms
- Endometrial Neoplasms
- Ovarian Neoplasms
- Adenoma
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