STELLA Trial: Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Staging of Endometrial/Ovarian Cancer - Full Text View

Purpose

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	Intervention
Endometrial Neoplasms Ovarian Neoplasms	Procedure: Transperitoneal laparoscopic aortic lymphadenectomy Procedure: Extraperitoneal laparoscopic aortic lymphadenectomy


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor)
Official Title:	STELLA Trial: Staging of Endometrial and Ovarian Cancer Comparing the Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Lymphadenectomy of Aortic Nodes

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Genetic and Rare Diseases Information Center resources: Ovarian Cancer

U.S. FDA Resources

Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

Primary Outcome Measures:

Number of lymph nodes [ Time Frame: After aortic lymphadenectomy is completed ] [ Designated as safety issue: No ]
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:

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


Estimated Enrollment:	60
Study Start Date:	June 2012
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

Eligibility


Genders 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01810874

Contacts


Contact: Berta Diaz-Feijoo, M.D., PhD	+34934893000	bdiaz@vhebron.net
Contact: Alejandro Correa-Paris, M.D.	+34654262915	correa.alejandro@gmail.com

Locations


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

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.


Responsible Party:	Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:	NCT01810874 History of Changes
Other Study ID Numbers:	STELLA
Study First Received:	March 12, 2013
Last Updated:	April 10, 2014
Health Authority:	Spain: Ethics Committee

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:


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

ClinicalTrials.gov processed this record on February 26, 2015