STELLA 2 Trial: Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Staging of Endometrial/Ovarian Cancer (STELLA-2)

October 23, 2019 updated by: Hospital Universitari Vall d'Hebron Research Institute

STELLA 2 Trial: Staging of Endometrial and Ovarian Cancer Comparing the Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Lymphadenectomy of Aortic Nodes, Evaluating Complications

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

208

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, 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

18 years to 85 years (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

  • Primary Purpose: Treatment
  • 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 lumbo-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
  • Transperitoneal laparoscopic lumbo-aortic lymphadenectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical complications
Time Frame: intraoperatively, within 30 days after surgery, and past 30 days after surgery up to 3 months after surgery

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of lymph nodes
Time Frame: Postoperatively (within 1 week), at the moment of histopathologic examination
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.
Postoperatively (within 1 week), at the moment of histopathologic examination
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
Hospital stay
Time Frame: Measured the day the patient is discharged (up to 100 days)
The number of days that patients stay in the hospital after surgery, measured in days from the day of the surgery to the day the patient is discharged from the hospital.
Measured the day the patient is discharged (up to 100 days)
Overall survival
Time Frame: up to 3 years after surgery
Number of patients alive after surgery.
up to 3 years after surgery
Disease-free survival
Time Frame: up to 3 years after surgery
Period of time in which there is no appearance of the symptoms or effects of the disease.
up to 3 years after surgery

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

European Regional Development Fund

Investigators

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

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 (Actual)

July 1, 2014

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

September 8, 2019

Study Registration Dates

First Submitted

October 14, 2015

First Submitted That Met QC Criteria

February 3, 2016

First Posted (Estimate)

February 8, 2016

Study Record Updates

Last Update Posted (Actual)

October 24, 2019

Last Update Submitted That Met QC Criteria

October 23, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P14/1817

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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