STELLA Trial: Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Staging of Endometrial/Ovarian Cancer

Study Overview
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Brief Summary
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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 endometrial or ovarian cancer.

Official Title
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STELLA Trial: Staging of Endometrial and Ovarian Cancer Comparing the Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Lymphadenectomy of Aortic Nodes

Conditions
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Endometrial Neoplasms, Ovarian Neoplasms

Intervention / Treatment
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* Procedure: Transperitoneal laparoscopic aortic lymphadenectomy
* Procedure: Extraperitoneal laparoscopic aortic lymphadenectomy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transperitoneal<br>Patients who where randomized to transperitoneal laparoscopic aortic lymphadenectomy. | Procedure: Transperitoneal laparoscopic aortic lymphadenectomy<br>* Aortic/para-aortic lymph nodes dissection and retrieval by transperitoneal laparoscopy; the intervention may be completed by robotic-assisted or traditional laparoscopy.<br>* Other names: Transperitoneal laparoscopic para-aortic lymphadenectomy;|
| Experimental: Extraperitoneal<br>Patients who where randomized to extraperitoneal laparoscopic aortic lymphadenectomy. | Procedure: Extraperitoneal laparoscopic aortic lymphadenectomy<br>* Aortic/para-aortic lymph nodes dissection and retrieval by extraperitoneal laparoscopy; the intervention may be completed by robotic-assisted or traditional laparoscopy.<br>* Other names: Retroperitoneal laparoscopic para-aortic lymphadenectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of lymph nodes | 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. | After aortic lymphadenectomy is completed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | 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. | At the time of the surgery | 
| Intraoperative complications | Number of patients presenting intraoperative complications. This variable is also classified according to the type of adverse outcome. | At the time of surgery | 
| Early Postoperative complications | Number of patients presenting postoperative complications. This variable is also classified according to the type of adverse outcome. | within 30 days after surgery | 
| Late Postoperative complications | Number of patients presenting postoperative complications. This variable is also classified according to the type of adverse outcome. | past 30 days after surgery | 
| Overall survival | Number of patients alive after surgery. | up to 3 years | 
| Disease-free survival | Metric: months. Period of time in which there is no appearance of the symptoms or effects of the disease. | up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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extraperitoneal, transperitoneal, laparoscopic aortic lymphadenectomy, endometrial ovarian cancer, ovarian cancer, surgical staging