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

Ovarian Neoplasms Clinical Trial

— STELLA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01810874
• Other study ID #: STELLA
• Status: Completed
• Phase: N/A
• First received: March 12, 2013
• Last updated: April 28, 2015
• Start date: June 2012
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Endometrial Neoplasms
• Neoplasms
• Ovarian Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona	Bacelona	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute	Fundación Mutua Madrileña

Country where clinical trial is conducted

Spain, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	After aortic lymphadenectomy is completed	No
Secondary	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.	At the time of the surgery	No
Secondary	Intraoperative complications	Number of patients presenting intraoperative complications. This variable is also classified according to the type of adverse outcome.	At the time of surgery	Yes
Secondary	Early Postoperative complications	Number of patients presenting postoperative complications. This variable is also classified according to the type of adverse outcome.	within 30 days after surgery	Yes
Secondary	Late Postoperative complications	Number of patients presenting postoperative complications. This variable is also classified according to the type of adverse outcome.	past 30 days after surgery	Yes
Secondary	Overall survival	Number of patients alive after surgery.	up to 3 years	No
Secondary	Disease-free survival	Metric: months. Period of time in which there is no appearance of the symptoms or effects of the disease.	up to 3 years	No