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

April 28, 2015 updated by: Hospital Universitari Vall d'Hebron Research Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Bacelona, Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Extraperitoneal
Patients who where randomized to extraperitoneal laparoscopic aortic lymphadenectomy.
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.
Other Names:
  • Extraperitoneal laparoscopic para-aortic lymphadenectomy
  • Retroperitoneal laparoscopic aortic lymphadenectomy
  • Retroperitoneal laparoscopic para-aortic lymphadenectomy
Active Comparator: Transperitoneal
Patients who where randomized to transperitoneal laparoscopic aortic lymphadenectomy.
Procedure: 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.
Other Names:
  • Transperitoneal laparoscopic para-aortic lymphadenectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of lymph nodes
Time Frame: After aortic lymphadenectomy is completed
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: At the time of the surgery
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
Intraoperative complications
Time Frame: At the time of surgery
Number of patients presenting intraoperative complications. This variable is also classified according to the type of adverse outcome.
At the time of surgery
Early Postoperative complications
Time Frame: within 30 days after surgery
Number of patients presenting postoperative complications. This variable is also classified according to the type of adverse outcome.
within 30 days after surgery
Late Postoperative complications
Time Frame: past 30 days after surgery
Number of patients presenting postoperative complications. This variable is also classified according to the type of adverse outcome.
past 30 days after surgery
Overall survival
Time Frame: up to 3 years
Number of patients alive after surgery.
up to 3 years
Disease-free survival
Time Frame: up to 3 years
Metric: months. Period of time in which there is no appearance of the symptoms or effects of the disease.
up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Collaborators

Fundación Mutua Madrileña

Investigators

  • Study Chair: Antonio Gil Moreno, M.D., PhD, Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
  • Study Director: Berta Díaz Feijoo, M.D., PhD, Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

March 12, 2013

First Submitted That Met QC Criteria

March 13, 2013

First Posted (Estimate)

March 14, 2013

Study Record Updates

Last Update Posted (Estimate)

April 29, 2015

Last Update Submitted That Met QC Criteria

April 28, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STELLA (Baylor College of Medicine)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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