NCT01810874

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 14, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 29, 2015

Status Verified

April 1, 2015

Enrollment Period

2.1 years

First QC Date

March 12, 2013

Last Update Submit

April 28, 2015

Conditions

Endometrial NeoplasmsOvarian Neoplasms

Keywords

extraperitonealtransperitoneallaparoscopic aortic lymphadenectomyendometrial ovarian cancerovarian cancersurgical staging

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Operative time

    At the time of the surgery

  • Intraoperative complications

    At the time of surgery

  • Early Postoperative complications

    within 30 days after surgery

  • Late Postoperative complications

    past 30 days after surgery

  • Overall survival

    up to 3 years

  • +1 more secondary outcomes

Study Arms (2)

Transperitoneal

ACTIVE COMPARATOR

Patients who where randomized to transperitoneal laparoscopic aortic lymphadenectomy.

Procedure: Transperitoneal laparoscopic aortic lymphadenectomy

Extraperitoneal

EXPERIMENTAL

Patients who where randomized to extraperitoneal laparoscopic aortic lymphadenectomy.

Procedure: Extraperitoneal laparoscopic aortic lymphadenectomy

Interventions

Transperitoneal laparoscopic aortic lymphadenectomyPROCEDURE

Aortic/para-aortic lymph nodes dissection and retrieval by transperitoneal laparoscopy; the intervention may be completed by robotic-assisted or traditional laparoscopy.

Also known as: Transperitoneal laparoscopic para-aortic lymphadenectomy
Transperitoneal
Extraperitoneal laparoscopic aortic lymphadenectomyPROCEDURE

Aortic/para-aortic lymph nodes dissection and retrieval by extraperitoneal laparoscopy; the intervention may be completed by robotic-assisted or traditional laparoscopy.

Also known as: Extraperitoneal laparoscopic para-aortic lymphadenectomy, Retroperitoneal laparoscopic aortic lymphadenectomy, Retroperitoneal laparoscopic para-aortic lymphadenectomy
Extraperitoneal

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

Bacelona, Barcelona, 08035, Spain

Location

Related Publications (8)

  • Gil-Moreno A, Franco-Camps S, Cabrera S, Perez-Benavente A, Martinez-Gomez 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.

    PMID: 20839058BACKGROUND

  • Gil-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: 18538379BACKGROUND

  • Gil-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: 18365538BACKGROUND

  • Gil-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: 16431320BACKGROUND

  • 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.

    PMID: 18835020BACKGROUND

  • 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.

    PMID: 19157527BACKGROUND

  • Franco-Camps S, Cabrera S, Perez-Benavente A, Diaz-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.

    PMID: 20580322BACKGROUND

  • Diaz-Feijoo B, Correa-Paris A, Perez-Benavente A, Franco-Camps S, Sanchez-Iglesias JL, Cabrera S, de la Torre J, Centeno C, Puig OP, Gil-Ibanez 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.

    PMID: 27098143DERIVED

MeSH Terms

Conditions

Endometrial NeoplasmsOvarian Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Antonio Gil Moreno, M.D., PhD

    Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

    STUDY CHAIR

  • Berta Díaz Feijoo, M.D., PhD

    Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2013

First Posted

March 14, 2013

Study Start

June 1, 2012

Primary Completion

July 1, 2014

Study Completion

April 1, 2015

Last Updated

April 29, 2015

Record last verified: 2015-04

Locations

ES(1)