NCT02676726

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 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

July 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 8, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2019

Completed
Last Updated

October 24, 2019

Status Verified

October 1, 2019

Enrollment Period

5.2 years

First QC Date

October 14, 2015

Last Update Submit

October 23, 2019

Conditions

Endometrial NeoplasmsOvarian Neoplasms

Keywords

extraperitonealtransperitoneallaparoscopic aortic lymphadenectomyendometrial cancerovarian cancersurgical staging

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Number of lymph nodes

    Postoperatively (within 1 week), at the moment of histopathologic examination

  • Operative time

    At the time of the surgery

  • Hospital stay

    Measured the day the patient is discharged (up to 100 days)

  • Overall survival

    up to 3 years after surgery

  • Disease-free survival

    up to 3 years after surgery

Study Arms (2)

Extraperitoneal

EXPERIMENTAL

Patients who where randomized to extraperitoneal laparoscopic aortic lymphadenectomy.

Procedure: Extraperitoneal Laparoscopic aortic lymphadenectomy

Transperitoneal

ACTIVE COMPARATOR

Patients who where randomized to transperitoneal laparoscopic aortic lymphadenectomy.

Procedure: Transperitoneal Laparoscopic aortic lymphadenectomy

Interventions

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 lumbo-aortic lymphadenectomy
Extraperitoneal
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 laparoscopic lumbo-aortic lymphadenectomy
Transperitoneal

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (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

Barcelona, 08035, Spain

Location

Related Publications (13)

  • Vasilev 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: 8641608BACKGROUND

  • 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

  • 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

  • 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, 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: 18607826BACKGROUND

  • 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.

    PMID: 24361579BACKGROUND

  • 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. No abstract available.

    PMID: 20188409BACKGROUND

  • 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.

    PMID: 18304622BACKGROUND

  • 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

  • Diaz-Feijoo B, Gil-Ibanez B, Perez-Benavente A, Martinez-Gomez X, Colas E, Sanchez-Iglesias JL, Cabrera-Diaz 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.

    PMID: 24231134BACKGROUND

  • Bebia V, Gil-Moreno A, Hernandez A, Gilabert-Estelles J, Franco-Camps S, de la Torre J, Siegrist J, Chipirliu A, Cabrera S, Bradbury M, Perez-Benavente A, Diaz-Feijoo B. Robot-assisted Extraperitoneal Para-aortic Lymphadenectomy Is Associated with Fewer Surgical Complications: A Post Hoc Analysis of the STELLA-2 Randomized Trial. J Minim Invasive Gynecol. 2021 Dec;28(12):2004-2012.e1. doi: 10.1016/j.jmig.2021.05.009. Epub 2021 May 20.

    PMID: 34022445DERIVED

  • Diaz-Feijoo B, Bebia V, Hernandez A, Gilabert-Estalles J, Franco-Camps S, de la Torre J, Segrist J, Chipirliu A, Cabrera S, Perez-Benavente A, Gil-Moreno A. Surgical complications comparing extraperitoneal vs transperitoneal laparoscopic aortic staging in early stage ovarian and endometrial cancer. Gynecol Oncol. 2021 Jan;160(1):83-90. doi: 10.1016/j.ygyno.2020.10.038. Epub 2020 Nov 5.

    PMID: 33160695DERIVED

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, MD, PhD

    Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

    STUDY CHAIR

  • Berta Diaz Feijoo, MD, PhD

    Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

    STUDY DIRECTOR

  • Alejandro Correa Paris, MD

    Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

    PRINCIPAL INVESTIGATOR

  • M. Assumpció Pérez-Benavente, MD, PhD

    Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

    PRINCIPAL INVESTIGATOR

  • Silvia Franco Camps, MD

    Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

    PRINCIPAL INVESTIGATOR

  • Jose Luis Sánchez Iglesias, MD, PhD

    Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

    PRINCIPAL INVESTIGATOR

  • Silvia Cabrera Díaz, MD, PhD

    Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

    PRINCIPAL INVESTIGATOR

  • Oriol Puig Puig, MD

    Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

    PRINCIPAL INVESTIGATOR

  • Javier De La Torre, MD, PhD

    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
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2015

First Posted

February 8, 2016

Study Start

July 1, 2014

Primary Completion

September 1, 2019

Study Completion

September 8, 2019

Last Updated

October 24, 2019

Record last verified: 2019-10

Locations

ES(1)