Skip to main content
OpenTrials
Completed

NCT Number: NCT02676726

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Endometrial Neoplasms Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

Barcelona, 08035, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extraperitoneal laparoscopic aortic lymphadenectomy

Procedure

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

Transperitoneal laparoscopic aortic lymphadenectomy

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Overall survival

    Time frame: up to 3 years after surgery

    Number of patients alive after surgery.

  5. 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.

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Collaborators

  • European Regional Development Fund

Registry information

Official study title

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

Acronym: STELLA-2

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Feb 8, 2016
Registry last updated
Oct 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.