STELLA 2 Trial: Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Staging of Endometrial/Ovarian Cancer

Not Applicable

Completed

• Conditions: Endometrial Neoplasms; Ovarian Neoplasms
• Interventions: Procedure: Transperitoneal Laparoscopic aortic lymphadenectomy; Procedure: Extraperitoneal Laparoscopic aortic lymphadenectomy

• Registration Number: NCT02676726
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2015-10-14
• Study First Submitted QC: 2016-02-03
• Study First Posted: 2016-02-08
• Primary Completion: 2019-09
• Study Completion: 2019-09-08
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-23
• Last Update Posted: 2019-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 208

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transperitoneal	Transperitoneal Laparoscopic aortic lymphadenectomy	Patients who where randomized to transperitoneal laparoscopic aortic lymphadenectomy.
Extraperitoneal	Extraperitoneal Laparoscopic aortic lymphadenectomy	Patients who where randomized to extraperitoneal laparoscopic aortic lymphadenectomy.

Primary Outcome Measures

Name	Time	Method
Surgical complications	intraoperatively, within 30 days after surgery, and past 30 days after surgery up to 3 months after surgery	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

Secondary Outcome Measures

Name	Time	Method
Overall survival	up to 3 years after surgery	Number of patients alive after surgery.
Operative time	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.
Number of lymph nodes	Postoperatively (within 1 week), at the moment of histopathologic examination	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.
Disease-free survival	up to 3 years after surgery	Period of time in which there is no appearance of the symptoms or effects of the disease.
Hospital stay	Measured the day the patient is discharged (up to 100 days)	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.

Trial Locations

Locations (1)

Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona; 🇪🇸 Barcelona, Spain