Status:
COMPLETED
STELLA Trial: Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Staging of Endometrial/Ovarian Cancer
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Collaborating Sponsors:
Fundación Mutua Madrileña
Conditions:
Endometrial Neoplasms
Ovarian Neoplasms
Eligibility:
FEMALE
Phase:
NA
Brief Summary
The purpose of this study is to determine whether the extraperitoneal approach is better than the transperitoneal approach for laparoscopic aortic lymphadenectomy for the surgical staging of endometri...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01810874
Start Date
June 1 2012
End Date
April 1 2015
Last Update
April 29 2015
Active Locations (1)
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1
Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
Bacelona, Barcelona, Spain, 08035