Clinical trial · Interventional
STELLA 2 Trial: Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Staging of Endometrial/Ovarian Cancer
STELLA 2 Trial: Staging of Endometrial and Ovarian Cancer Comparing the Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Lymphadenectomy of Aortic Nodes, Evaluating Complications
NCT02676726CI-TRIAL-00041273STELLA-2completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Neoplasms | Endometrial Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Extraperitoneal Laparoscopic aortic lymphadenectomy | Procedure | — | UNRESOLVED |
| Transperitoneal Laparoscopic aortic lymphadenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Extraperitoneal
- description
- Patients who where randomized to extraperitoneal laparoscopic aortic lymphadenectomy.
- interventionNames
- Procedure: Extraperitoneal Laparoscopic aortic lymphadenectomy
- type
- ACTIVE_COMPARATOR
- label
- Transperitoneal
- description
- Patients who where randomized to transperitoneal laparoscopic aortic lymphadenectomy.
- interventionNames
- Procedure: Transperitoneal Laparoscopic aortic lymphadenectomy
Primary outcomes (1)
- measure
- Surgical complications
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (13)
- BACKGROUNDVasilev SA, McGonigle KF. Extraperitoneal laparoscopic para-aortic lymph node dissection. Gynecol Oncol. 1996 Jun;61(3):315-20. doi: 10.1006/gyno.1996.0149. PMID 8641608
- BACKGROUNDDowdy 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. PMID 18835020
- BACKGROUNDGil-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. PMID 18365538
- BACKGROUNDGil-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. PMID 16431320
- BACKGROUNDGil-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. PMID 18538379
- BACKGROUNDGil-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. PMID 18607826
- BACKGROUNDPakish 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.