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

Primary Purpose

Endometrial Neoplasms, Ovarian Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Extraperitoneal Laparoscopic aortic lymphadenectomy
Transperitoneal Laparoscopic aortic lymphadenectomy
Sponsored by
Hospital Universitari Vall d'Hebron Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Neoplasms focused on measuring extraperitoneal, transperitoneal, laparoscopic aortic lymphadenectomy, endometrial cancer, ovarian cancer, surgical staging

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Extraperitoneal

Transperitoneal

Arm Description

Patients who where randomized to extraperitoneal laparoscopic aortic lymphadenectomy.

Patients who where randomized to transperitoneal laparoscopic aortic lymphadenectomy.

Outcomes

Primary Outcome Measures

Surgical complications
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 Outcome Measures

Number of lymph nodes
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.
Operative time
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.
Hospital stay
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.
Overall survival
Number of patients alive after surgery.
Disease-free survival
Period of time in which there is no appearance of the symptoms or effects of the disease.

Full Information

First Posted
October 14, 2015
Last Updated
October 23, 2019
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
European Regional Development Fund
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1. Study Identification

Unique Protocol Identification Number
NCT02676726
Brief Title
STELLA 2 Trial: Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Staging of Endometrial/Ovarian Cancer
Acronym
STELLA-2
Official Title
STELLA 2 Trial: Staging of Endometrial and Ovarian Cancer Comparing the Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Lymphadenectomy of Aortic Nodes, Evaluating Complications
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
July 2014 (Actual)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
September 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
European Regional Development Fund

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Neoplasms, Ovarian Neoplasms
Keywords
extraperitoneal, transperitoneal, laparoscopic aortic lymphadenectomy, endometrial cancer, ovarian cancer, surgical staging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Extraperitoneal
Arm Type
Experimental
Arm Description
Patients who where randomized to extraperitoneal laparoscopic aortic lymphadenectomy.
Arm Title
Transperitoneal
Arm Type
Active Comparator
Arm Description
Patients who where randomized to transperitoneal laparoscopic aortic lymphadenectomy.
Intervention Type
Procedure
Intervention Name(s)
Extraperitoneal Laparoscopic aortic lymphadenectomy
Other Intervention Name(s)
Extraperitoneal laparoscopic para-aortic lymphadenectomy, Retroperitoneal laparoscopic lumbo-aortic lymphadenectomy
Intervention Description
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
Intervention Name(s)
Transperitoneal Laparoscopic aortic lymphadenectomy
Other Intervention Name(s)
Transperitoneal laparoscopic para-aortic lymphadenectomy, Transperitoneal laparoscopic lumbo-aortic lymphadenectomy
Intervention Description
Aortic/para-aortic lymph nodes dissection and retrieval by transperitoneal laparoscopy; the intervention may be completed by robotic-assisted or traditional laparoscopy.
Primary Outcome Measure Information:
Title
Surgical complications
Description
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
Time Frame
intraoperatively, within 30 days after surgery, and past 30 days after surgery up to 3 months after surgery
Secondary Outcome Measure Information:
Title
Number of lymph nodes
Description
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.
Time Frame
Postoperatively (within 1 week), at the moment of histopathologic examination
Title
Operative time
Description
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.
Time Frame
At the time of the surgery
Title
Hospital stay
Description
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.
Time Frame
Measured the day the patient is discharged (up to 100 days)
Title
Overall survival
Description
Number of patients alive after surgery.
Time Frame
up to 3 years after surgery
Title
Disease-free survival
Description
Period of time in which there is no appearance of the symptoms or effects of the disease.
Time Frame
up to 3 years after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Gil Moreno, MD, PhD
Organizational Affiliation
Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Berta Diaz Feijoo, MD, PhD
Organizational Affiliation
Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alejandro Correa Paris, MD
Organizational Affiliation
Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
M. Assumpció Pérez-Benavente, MD, PhD
Organizational Affiliation
Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Silvia Franco Camps, MD
Organizational Affiliation
Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jose Luis Sánchez Iglesias, MD, PhD
Organizational Affiliation
Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Silvia Cabrera Díaz, MD, PhD
Organizational Affiliation
Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Oriol Puig Puig, MD
Organizational Affiliation
Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Javier De La Torre, MD, PhD
Organizational Affiliation
Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
City
Barcelona
ZIP/Postal Code
08035
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
8641608
Citation
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Results Reference
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PubMed Identifier
18365538
Citation
Gil-Moreno A, Maffuz A, Diaz-Feijoo B, Puig O, Martinez-Palones JM, Perez A, Garcia A, Xercavins J. Modified approach for extraperitoneal laparoscopic staging for locally advanced cervical cancer. J Exp Clin Cancer Res. 2007 Dec;26(4):451-8.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
18538379
Citation
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STELLA 2 Trial: Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Staging of Endometrial/Ovarian Cancer

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