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

NCT02676726CompletedNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Enrollment

208

Start Date

2014-07-01

Completion Date

2019-09-01

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Extraperitoneal Laparoscopic aortic lymphadenectomyTransperitoneal Laparoscopic aortic lymphadenectomy

Conditions

Endometrial NeoplasmsOvarian Neoplasms

Eligibility

Age Range

18 Years – 85 Years

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

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

Time frame: intraoperatively, within 30 days after surgery, and past 30 days after surgery up to 3 months after surgery

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Measured the day the patient is discharged (up to 100 days)

Overall survival

Number of patients alive after surgery.

Time frame: 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.

Time frame: up to 3 years after surgery

Locations

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

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