STELLA Trial: Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Staging of Endometrial/Ovarian Cancer (STELLA)
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ClinicalTrials.gov Identifier: NCT01810874 |
Recruitment Status
:
Completed
First Posted
: March 14, 2013
Last Update Posted
: April 29, 2015
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Condition or disease | Intervention/treatment | Phase |
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Endometrial Neoplasms Ovarian Neoplasms | Procedure: Transperitoneal laparoscopic aortic lymphadenectomy Procedure: Extraperitoneal laparoscopic aortic lymphadenectomy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Official Title: | STELLA Trial: Staging of Endometrial and Ovarian Cancer Comparing the Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Lymphadenectomy of Aortic Nodes |
Study Start Date : | June 2012 |
Actual Primary Completion Date : | July 2014 |
Actual Study Completion Date : | April 2015 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Transperitoneal
Patients who where randomized to transperitoneal laparoscopic aortic lymphadenectomy.
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Procedure: Transperitoneal laparoscopic aortic lymphadenectomy
Aortic/para-aortic lymph nodes dissection and retrieval by transperitoneal laparoscopy; the intervention may be completed by robotic-assisted or traditional laparoscopy.
Other Name: Transperitoneal laparoscopic para-aortic lymphadenectomy
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Experimental: Extraperitoneal
Patients who where randomized to extraperitoneal laparoscopic aortic lymphadenectomy.
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Procedure: Extraperitoneal laparoscopic aortic lymphadenectomy
Aortic/para-aortic lymph nodes dissection and retrieval by extraperitoneal laparoscopy; the intervention may be completed by robotic-assisted or traditional laparoscopy.
Other Names:
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- Number of lymph nodes [ Time Frame: After aortic lymphadenectomy is completed ]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.
- Operative time [ Time Frame: At the time of the surgery ]Total duration of surgery (from initial skin incision to end of skin suture), and total aortic lymphadenectomy time (time spent since the beginning of aortic lymphadenectomy to its completion). Metric: minutes.
- Intraoperative complications [ Time Frame: At the time of surgery ]Number of patients presenting intraoperative complications. This variable is also classified according to the type of adverse outcome.
- Early Postoperative complications [ Time Frame: within 30 days after surgery ]Number of patients presenting postoperative complications. This variable is also classified according to the type of adverse outcome.
- Late Postoperative complications [ Time Frame: past 30 days after surgery ]Number of patients presenting postoperative complications. This variable is also classified according to the type of adverse outcome.
- Overall survival [ Time Frame: up to 3 years ]Number of patients alive after surgery.
- Disease-free survival [ Time Frame: up to 3 years ]Metric: months. Period of time in which there is no appearance of the symptoms or effects of the disease.

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810874
Spain | |
Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona | |
Bacelona, Barcelona, Spain, 08035 |
Study Chair: | Antonio Gil Moreno, M.D., PhD | Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona | |
Study Director: | Berta Díaz Feijoo, M.D., PhD | Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona | |
Principal Investigator: | Jose Luis Sánchez, M.D. | Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona | |
Principal Investigator: | Alejandro Correa Paris, M.D. | Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona | |
Principal Investigator: | M. Assumpció Pérez-Benavente, M.D., PhD | Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona | |
Principal Investigator: | Silvia Cabrera Díaz, M.D. | Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona | |
Principal Investigator: | Silvia Franco Camps, M.D. | Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona | |
Principal Investigator: | Oriol Puig Puig, M.D. | Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Hospital Universitari Vall d'Hebron Research Institute |
ClinicalTrials.gov Identifier: | NCT01810874 History of Changes |
Other Study ID Numbers: |
STELLA |
First Posted: | March 14, 2013 Key Record Dates |
Last Update Posted: | April 29, 2015 |
Last Verified: | April 2015 |
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
extraperitoneal transperitoneal laparoscopic aortic lymphadenectomy |
endometrial ovarian cancer ovarian cancer surgical staging |
Additional relevant MeSH terms:
Neoplasms Ovarian Neoplasms Endometrial Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases |
Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Uterine Neoplasms Uterine Diseases |