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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Hospital Universitari Vall d'Hebron Research Institute
Sponsor:
Collaborator:
Fundación Mutua Madrileña
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT01810874
First received: March 12, 2013
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Endometrial Neoplasms
Ovarian Neoplasms
Procedure: Transperitoneal laparoscopic aortic lymphadenectomy
Procedure: Extraperitoneal laparoscopic aortic lymphadenectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: STELLA Trial: Staging of Endometrial and Ovarian Cancer Comparing the Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Lymphadenectomy of Aortic Nodes

Resource links provided by NLM:


Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

Primary Outcome Measures:
  • Number of lymph nodes [ Time Frame: After aortic lymphadenectomy is completed ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Operative time [ Time Frame: At the time of the surgery ] [ Designated as safety issue: No ]
    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.

  • Intraoperative complications [ Time Frame: At the time of surgery ] [ Designated as safety issue: Yes ]
    Number of patients presenting intraoperative complications. This variable is also classified according to the type of adverse outcome.

  • Early Postoperative complications [ Time Frame: within 3 days after surgery ] [ Designated as safety issue: Yes ]
    Number of patients presenting postoperative complications. This variable is also classified according to the type of adverse outcome.

  • Late Postoperative complications [ Time Frame: past 3 days after surgery ] [ Designated as safety issue: Yes ]
    Number of patients presenting postoperative complications. This variable is also classified according to the type of adverse outcome.

  • Overall survival [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    Number of patients alive after surgery.

  • Disease-free survival [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    Metric: months. Period of time in which there is no appearance of the symptoms or effects of the disease.


Estimated Enrollment: 60
Study Start Date: June 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Transperitoneal laparoscopic para-aortic lymphadenectomy
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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01810874

Contacts
Contact: Berta Diaz-Feijoo, M.D., PhD +34934893000 bdiaz@vhebron.net
Contact: Alejandro Correa-Paris, M.D. +34654262915 correa.alejandro@gmail.com

Locations
Spain
Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona Recruiting
Bacelona, Barcelona, Spain, 08035
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
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
  More Information

Publications:

Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT01810874     History of Changes
Other Study ID Numbers: STELLA
Study First Received: March 12, 2013
Last Updated: April 10, 2014
Health Authority: Spain: Ethics Committee

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
extraperitoneal
transperitoneal
laparoscopic aortic lymphadenectomy
endometrial ovarian cancer
ovarian cancer
surgical staging

Additional relevant MeSH terms:
Endometrial Neoplasms
Neoplasms
Ovarian Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on July 22, 2014