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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Endometrial Neoplasms; Ovarian Neoplasms	Procedure: Transperitoneal laparoscopic aortic lymphadenectomy; Procedure: Extraperitoneal laparoscopic aortic lymphadenectomy	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Official Title:	STELLA Trial: Staging of Endometrial and Ovarian Cancer Comparing the Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Lymphadenectomy of Aortic Nodes
Study Start Date :	June 2012
Actual Primary Completion Date :	July 2014
Actual Study Completion Date :	April 2015

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: Transperitoneal; Patients who where randomized to transperitoneal laparoscopic aortic lymphadenectomy.	Procedure: Transperitoneal laparoscopic aortic lymphadenectomy; Aortic/para-aortic lymph nodes dissection and retrieval by transperitoneal laparoscopy; the intervention may be completed by robotic-assisted or traditional laparoscopy.; Other Name: Transperitoneal laparoscopic para-aortic lymphadenectomy
Experimental: Extraperitoneal; Patients who where randomized to extraperitoneal laparoscopic aortic lymphadenectomy.	Procedure: Extraperitoneal laparoscopic aortic lymphadenectomy; Aortic/para-aortic lymph nodes dissection and retrieval by extraperitoneal laparoscopy; the intervention may be completed by robotic-assisted or traditional laparoscopy.; Other Names: Extraperitoneal laparoscopic para-aortic lymphadenectomy; Retroperitoneal laparoscopic aortic lymphadenectomy; Retroperitoneal laparoscopic para-aortic lymphadenectomy

Outcome Measures

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Primary Outcome Measures :

1. Number of lymph nodes [ Time Frame: After aortic lymphadenectomy is completed ]
   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.

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Spain
Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
Bacelona, Barcelona, Spain, 08035

Sponsors and Collaborators

Hospital Universitari Vall d'Hebron Research Institute

Fundación Mutua Madrileña

Investigators

Study Chair:	Antonio Gil Moreno, M.D., PhD	Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
Study Director:	Berta Díaz Feijoo, M.D., PhD	Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
Principal Investigator:	Jose Luis Sánchez, M.D.	Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
Principal Investigator:	Alejandro Correa Paris, M.D.	Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
Principal Investigator:	M. Assumpció Pérez-Benavente, M.D., PhD	Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
Principal Investigator:	Silvia Cabrera Díaz, M.D.	Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
Principal Investigator:	Silvia Franco Camps, M.D.	Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
Principal Investigator:	Oriol Puig Puig, M.D.	Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Gil-Moreno A, Franco-Camps S, Cabrera S, Pérez-Benavente A, Martínez-Gómez 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.

Gil-Moreno A, Díaz-Feijoo B, Pérez-Benavente A, del Campo JM, Xercavins J, Martínez-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.

Gil-Moreno A, Maffuz A, Díaz-Feijoo B, Puig O, Martínez-Palones JM, Pérez A, García 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.

Gil-Moreno A, Díaz-Feijoo B, Morchón 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.

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.

Magrina JF, Kho R, Montero RP, Magtibay PM, Pawlina W. Robotic extraperitoneal aortic lymphadenectomy: Development of a technique. Gynecol Oncol. 2009 Apr;113(1):32-5. doi: 10.1016/j.ygyno.2008.11.038. Epub 2009 Jan 21.

Franco-Camps S, Cabrera S, Pérez-Benavente A, Díaz-Feijoo B, Bradbury M, Xercavins J, Gil-Moreno A. Extraperitoneal laparoscopic approach for diagnosis and treatment of aortic lymph node recurrence in gynecologic malignancy. J Minim Invasive Gynecol. 2010 Sep-Oct;17(5):570-5. doi: 10.1016/j.jmig.2010.03.020. Epub 2010 Jun 30.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Díaz-Feijoo B, Correa-Paris A, Pérez-Benavente A, Franco-Camps S, Sánchez-Iglesias JL, Cabrera S, de la Torre J, Centeno C, Puig OP, Gil-Ibañez B, Colas E, Magrina J, Gil-Moreno A. Prospective Randomized Trial Comparing Transperitoneal Versus Extraperitoneal Laparoscopic Aortic Lymphadenectomy for Surgical Staging of Endometrial and Ovarian Cancer: The STELLA Trial. Ann Surg Oncol. 2016 Sep;23(9):2966-74. doi: 10.1245/s10434-016-5229-9. Epub 2016 Apr 20.

Responsible Party:	Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:	NCT01810874 History of Changes
Other Study ID Numbers:	STELLA
First Posted:	March 14, 2013
Last Update Posted:	April 29, 2015
Last Verified:	April 2015

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:

extraperitoneal; transperitoneal; laparoscopic aortic lymphadenectomy	endometrial ovarian cancer; ovarian cancer; surgical staging

Additional relevant MeSH terms:

Neoplasms; Ovarian Neoplasms; Endometrial Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases	Genital Diseases, Female; Genital Neoplasms, Female; Urogenital Neoplasms; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases