STELLA 2 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 or not there are more complications in the extraperitoneal compared with the transperitoneal approach for laparoscopic aortic lymphadenectomy for the surgical staging of endometrial or ovarian cancer

Official Title
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STELLA 2 Trial: Staging of Endometrial and Ovarian Cancer Comparing the Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Lymphadenectomy of Aortic Nodes, Evaluating Complications

Conditions
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Endometrial Neoplasms, Ovarian Neoplasms

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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 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 lumbo-aortic lymphadenectomy;|
| 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 lumbo-aortic lymphadenectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical complications | Composite outcome defined by including at least one of the following: Total estimated blood loss > 500 mL during surgery Blood transfusion Intraoperative complication classified as Dindo grade III or worse, related to the aortic lymphadenectomy Early postoperative complication (within 30 days after surgery) classified as Dindo grade III or worse, related to the aortic lymphadenectomy Late postoperative complication (past 30 days after surgery) classified as Dindo grade III or worse, related to the aortic lymphadenectomy Conversion to laparotomy during the aortic lymphadenectomy Inability to complete the aortic lymphadenectomy | intraoperatively, within 30 days after surgery, and past 30 days after surgery up to 3 months after surgery | 

Secondary 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. | Postoperatively (within 1 week), at the moment of histopathologic examination | 
| 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 | 
| Hospital stay | The number of days that patients stay in the hospital after surgery, measured in days from the day of the surgery to the day the patient is discharged from the hospital. | Measured the day the patient is discharged (up to 100 days) | 
| Overall survival | Number of patients alive after surgery. | up to 3 years after surgery | 
| Disease-free survival | Period of time in which there is no appearance of the symptoms or effects of the disease. | up to 3 years after surgery | 

 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 cancer, ovarian cancer, surgical staging