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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2019-09-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01810874

Endometrial Neoplasms Ovarian Neoplasms

COMPLETED NA

Mapping Sentinel Lymph Node in Initial Stages of Ovarian Cancer

NCT05184140

Ovarian Cancer Sentinel Lymph Node

UNKNOWN NA

Laparoscopic Staging in Patients With Ovarian, Fallopian Tube, or Other Primary Abdominal Cancers

NCT00002538

Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer

COMPLETED PHASE2

Availability & Effect of Post-OP Ketorolac on Ovarian, Fallopian Tube or Primary Peritoneal Cancer

NCT01670799

Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer

COMPLETED EARLY_PHASE1

Taurolidine in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

NCT00021034

Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endometrial Neoplasms Ovarian Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Extraperitoneal

Patients who where randomized to extraperitoneal laparoscopic aortic lymphadenectomy.

Group Type EXPERIMENTAL

Extraperitoneal Laparoscopic aortic lymphadenectomy

Intervention Type PROCEDURE

Aortic/para-aortic lymph nodes dissection and retrieval by extraperitoneal laparoscopy; the intervention may be completed by robotic-assisted or traditional laparoscopy.

Transperitoneal

Patients who where randomized to transperitoneal laparoscopic aortic lymphadenectomy.

Group Type ACTIVE_COMPARATOR

Transperitoneal Laparoscopic aortic lymphadenectomy

Intervention Type PROCEDURE

Aortic/para-aortic lymph nodes dissection and retrieval by transperitoneal laparoscopy; the intervention may be completed by robotic-assisted or traditional laparoscopy.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Extraperitoneal laparoscopic para-aortic lymphadenectomy Retroperitoneal laparoscopic lumbo-aortic lymphadenectomy Transperitoneal laparoscopic para-aortic lymphadenectomy Transperitoneal laparoscopic lumbo-aortic lymphadenectomy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR