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Completed

NCT Number: NCT01810874

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

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.

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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

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

Bacelona, 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

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

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 aortic lymphadenectomy, Retroperitoneal laparoscopic para-aortic lymphadenectomy

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Overall survival

    Time frame: up to 3 years

    Number of patients alive after surgery.

  6. 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.

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Collaborators

  • Fundación Mutua Madrileña

Registry information

Official study title

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

Acronym: STELLA

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Mar 14, 2013
Registry last updated
Apr 29, 2015

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.

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