Clinical trial NCT02676726: STELLA 2 Trial: Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Staging of Endometrial/Ovarian Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Neoplasms
Ovarian Neoplasms
Keywords: extraperitoneal
transperitoneal
laparoscopic aortic lymphadenectomy
endometrial cancer
ovarian cancer
surgical staging
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: European Regional Development Fund
First posted: 2016-02-08
Enrollment: 208
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Surgical complications
timeFrame: intraoperatively, within 30 days after surgery, and past 30 days after surgery up to 3 months after surgery
Secondary outcomes:
measure: Number of lymph nodes
timeFrame: Postoperatively (within 1 week), at the moment of histopathologic examination
measure: Operative time
timeFrame: At the time of the surgery
measure: Hospital stay
timeFrame: Measured the day the patient is discharged (up to 100 days)
measure: Overall survival
timeFrame: up to 3 years after surgery
measure: Disease-free survival
timeFrame: up to 3 years after surgery
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
Study officials:
affiliation: Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
name: Antonio Gil Moreno, MD, PhD
role: STUDY_CHAIR
affiliation: Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
name: Berta Diaz Feijoo, MD, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
name: Alejandro Correa Paris, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
name: M. Assumpció Pérez-Benavente, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
name: Silvia Franco Camps, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
name: Jose Luis Sánchez Iglesias, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
name: Silvia Cabrera Díaz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
name: Oriol Puig Puig, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
name: Javier De La Torre, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Dowdy SC, Aletti G, Cliby WA, Podratz KC, Mariani A. Extra-peritoneal laparoscopic para-aortic lymphadenectomy--a prospective cohort study of 293 patients with endometrial cancer. Gynecol Oncol. 2008 Dec;111(3):418-24. doi: 10.1016/j.ygyno.2008.08.021. Epub 2008 Oct 2.
citation: Gil-Moreno A, Maffuz A, Diaz-Feijoo B, Puig O, Martinez-Palones JM, Perez A, Garcia A, Xercavins J. Modified approach for extraperitoneal laparoscopic staging for locally advanced cervical cancer. J Exp Clin Cancer Res. 2007 Dec;26(4):451-8.
citation: Gil-Moreno A, Diaz-Feijoo B, Morchon S, Xercavins J. Analysis of survival after laparoscopic-assisted vaginal hysterectomy compared with the conventional abdominal approach for early-stage endometrial carcinoma: a review of the literature. J Minim Invasive Gynecol. 2006 Jan-Feb;13(1):26-35. doi: 10.1016/j.jmig.2005.08.013.
citation: Gil-Moreno A, Diaz-Feijoo B, Perez-Benavente A, del Campo JM, Xercavins J, Martinez-Palones JM. Impact of extraperitoneal lymphadenectomy on treatment and survival in patients with locally advanced cervical cancer. Gynecol Oncol. 2008 Sep;110(3 Suppl 2):S33-5. doi: 10.1016/j.ygyno.2008.03.024. Epub 2008 Jun 5.
citation: Gil-Moreno A, Franco-Camps S, Diaz-Feijoo B, Perez-Benavente A, Martinez-Palones JM, Del Campo JM, Parera M, Verges R, Castellvi J, Xercavins J. Usefulness of extraperitoneal laparoscopic paraaortic lymphadenectomy for lymph node recurrence in gynecologic malignancy. Acta Obstet Gynecol Scand. 2008;87(7):723-30. doi: 10.1080/00016340802136343.
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citation: Gil-Moreno A, Franco-Camps S, Cabrera S, Perez-Benavente A, Martinez-Gomez X, Garcia A, Xercavins J. Pretherapeutic extraperitoneal laparoscopic staging of bulky or locally advanced cervical cancer. Ann Surg Oncol. 2011 Feb;18(2):482-9. doi: 10.1245/s10434-010-1320-9. Epub 2010 Sep 14.
citation: Diaz-Feijoo B, Gil-Ibanez B, Perez-Benavente A, Martinez-Gomez X, Colas E, Sanchez-Iglesias JL, Cabrera-Diaz S, Puig-Puig O, Magrina JF, Gil-Moreno A. Comparison of robotic-assisted vs conventional laparoscopy for extraperitoneal paraaortic lymphadenectomy. Gynecol Oncol. 2014 Jan;132(1):98-101. doi: 10.1016/j.ygyno.2013.11.004. Epub 2013 Nov 11.
citation: Bebia V, Gil-Moreno A, Hernandez A, Gilabert-Estelles J, Franco-Camps S, de la Torre J, Siegrist J, Chipirliu A, Cabrera S, Bradbury M, Perez-Benavente A, Diaz-Feijoo B. Robot-assisted Extraperitoneal Para-aortic Lymphadenectomy Is Associated with Fewer Surgical Complications: A Post Hoc Analysis of the STELLA-2 Randomized Trial. J Minim Invasive Gynecol. 2021 Dec;28(12):2004-2012.e1. doi: 10.1016/j.jmig.2021.05.009. Epub 2021 May 20.
citation: Diaz-Feijoo B, Bebia V, Hernandez A, Gilabert-Estalles J, Franco-Camps S, de la Torre J, Segrist J, Chipirliu A, Cabrera S, Perez-Benavente A, Gil-Moreno A. Surgical complications comparing extraperitoneal vs transperitoneal laparoscopic aortic staging in early stage ovarian and endometrial cancer. Gynecol Oncol. 2021 Jan;160(1):83-90. doi: 10.1016/j.ygyno.2020.10.038. Epub 2020 Nov 5.