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Endometrial NeoplasmsSTELLANCT01810874

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

A study testing Transperitoneal laparoscopic aortic lymphadenectomy and Extraperitoneal laparoscopic aortic lymphadenectomy in people with Endometrial Neoplasms and Ovarian Neoplasms, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Endometrial Neoplasms, Ovarian Neoplasms
What is being tested?
Transperitoneal laparoscopic aortic lymphadenectomy and Extraperitoneal laparoscopic aortic lymphadenectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSpain
Study dates
Jun 2012to Apr 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

    Bacelona, Barcelona, 08035

Other trials in Spain

About this study

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

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.

Being tested
Transperitoneal laparoscopic aortic lymphadenectomy, Extraperitoneal laparoscopic aortic lymphadenectomy
Keywords
extraperitoneal, transperitoneal, laparoscopic aortic lymphadenectomy, endometrial ovarian cancer, ovarian cancer, surgical staging
Medical subject headings
Endometrial Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transperitoneal laparoscopic aortic lymphadenectomyProcedure or surgery

    Also called Transperitoneal laparoscopic para-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 lymphadenectomyProcedure or surgery

    Also called Extraperitoneal laparoscopic para-aortic lymphadenectomy, Retroperitoneal laparoscopic aortic lymphadenectomy, Retroperitoneal laparoscopic para-aortic lymphadenectomy

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

Study groups in NCT01810874
Study groupRoleWhat they receive
TransperitonealActive comparatorPatients who where randomized to transperitoneal laparoscopic aortic lymphadenectomy.
Receives: Procedure: Transperitoneal laparoscopic aortic lymphadenectomy
ExtraperitonealExperimentalPatients who where randomized to extraperitoneal laparoscopic aortic lymphadenectomy.
Receives: Procedure: Extraperitoneal laparoscopic aortic lymphadenectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: After aortic lymphadenectomy is completed

Secondary outcomes (6)

  1. 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.

    Measured: At the time of the surgery

  2. Intraoperative complications

    Number of patients presenting intraoperative complications. This variable is also classified according to the type of adverse outcome.

    Measured: At the time of surgery

  3. Early Postoperative complications

    Number of patients presenting postoperative complications. This variable is also classified according to the type of adverse outcome.

    Measured: within 30 days after surgery

  4. Late Postoperative complications

    Number of patients presenting postoperative complications. This variable is also classified according to the type of adverse outcome.

    Measured: past 30 days after surgery

  5. Overall survival

    Number of patients alive after surgery.

    Measured: up to 3 years

  6. Disease-free survival

    Metric: months. Period of time in which there is no appearance of the symptoms or effects of the disease.

    Measured: up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2013 (estimated)
  2. Study startJun 2012
  3. Primary completionJul 2014
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01810874
Sponsor's protocol ID
STELLA
Acronym
STELLA
Status last verified
Apr 2015
First submitted
12 Mar 2013
Last updated
29 Apr 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20839058

  • 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.

    PubMed 18538379

  • 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.

    PubMed 18365538

  • 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.

    PubMed 16431320

  • 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.

    PubMed 18835020

  • 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.

    PubMed 19157527

  • 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.

    PubMed 20580322

  • 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.

    PubMed 27098143

Questions about this trial

What is this clinical trial studying?

A study testing Transperitoneal laparoscopic aortic lymphadenectomy and Extraperitoneal laparoscopic aortic lymphadenectomy in people with Endometrial Neoplasms and Ovarian Neoplasms, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of lymph nodes (time frame: After aortic lymphadenectomy is completed). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01810874, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2015.

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