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

Ovarian Neoplasms Clinical Trial

— STELLA-2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02676726
• Other study ID #: P14/1817
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: September 8, 2019

Study information

• Verified date: October 2019
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: September 8, 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Endometrial Neoplasms
• Neoplasms
• Ovarian Neoplasms

Intervention

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.
• 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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute	European Regional Development Fund

Country where clinical trial is conducted

Spain, 

References & Publications (11)

Díaz-Feijoo B, Gil-Ibáñez B, Pérez-Benavente A, Martínez-Gómez X, Colás E, Sánchez-Iglesias JL, Cabrera-Díaz 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. — View 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. — View Citation

Dowdy SC, Mariani A. Lymphadenectomy in endometrial cancer: when, not if. Lancet. 2010 Apr 3;375(9721):1138-40. doi: 10.1016/S0140-6736(09)62068-7. Epub 2010 Feb 24. — 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, Franco-Camps S, Díaz-Feijoo B, Pérez-Benavente A, Martínez-Palones JM, Del Campo JM, Parera M, Verges R, Castellví 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. — 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

Mariani A, Dowdy SC, Cliby WA, Gostout BS, Jones MB, Wilson TO, Podratz KC. Prospective assessment of lymphatic dissemination in endometrial cancer: a paradigm shift in surgical staging. Gynecol Oncol. 2008 Apr;109(1):11-8. doi: 10.1016/j.ygyno.2008.01.023. Epub 2008 Mar 4. — View Citation

Pakish J, Soliman PT, Frumovitz M, Westin SN, Schmeler KM, Reis RD, Munsell MF, Ramirez PT. A comparison of extraperitoneal versus transperitoneal laparoscopic or robotic para-aortic lymphadenectomy for staging of endometrial carcinoma. Gynecol Oncol. 2014 Feb;132(2):366-71. doi: 10.1016/j.ygyno.2013.12.019. Epub 2013 Dec 20. — View Citation

Vasilev SA, McGonigle KF. Extraperitoneal laparoscopic para-aortic lymph node dissection. Gynecol Oncol. 1996 Jun;61(3):315-20. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	intraoperatively, within 30 days after surgery, and past 30 days after surgery up to 3 months after surgery
Secondary	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.	Postoperatively (within 1 week), at the moment of histopathologic examination
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
Secondary	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.	Measured the day the patient is discharged (up to 100 days)
Secondary	Overall survival	Number of patients alive after surgery.	up to 3 years after surgery
Secondary	Disease-free survival	Period of time in which there is no appearance of the symptoms or effects of the disease.	up to 3 years after surgery