Lower-Limb Drainage Mapping in Pelvic Lymphadenectomy for Gynaecological Cancer (SENTIJAMBE)
January 6, 2023 updated by: Assistance Publique - Hôpitaux de Paris
Individualisation du Drainage Lymphatique Des Membres inférieurs Lors du Curage Pelvien Pour Cancer gynécologique
The purpose of this study is to evaluate the feasibility of an isotopic technique to identify, and to map the lower-limb drainage nodes during pelvic lymphadenectomy for gynaecological cancers.
The diagnostic value of our mapping method will be assessed, and we will determine the incidence of lymhedema.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Pelvic lymphadenectomy is associated with a significant risk of lower-limb lymphedema.
In this study, we evaluate the feasibility of identifying the lower-limb drainage nodes (LLDNs) during pelvic lymphadenectomy for gynaecological cancers using an isotopic detection technique with a preoperative radiopharmaceutical injection into both feet Secondary objectives are to map lower-limb drainage, to assess the diagnostic value of our mapping technique, and to determine the incidence of lymphedema.
LLDN mapping may allow the preservation of LLDNs, thereby decreasing the risk of lower-limb lymphedema and improving quality of life.
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ile-de-France
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Paris, Ile-de-France, France, 75
- HEGP
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
Female patients 18 years of age or older with indication of pelvic lymphadenectomy for gynaecological malignancy:
- High risk endometrial cancer (stage IB type I grade 3, stage I type II, stage> IB) or with metastatic sentinel lymph node,
- Early cervical cancer, or with metastatic sentinel lymph node,
- Ovarian cancer.
- Must provide her signed and informed consent
- Beneficiary of a health insurance
- Having received a medical examination
Exclusion Criteria:
- Contraindication to pelvic lymphadenectomy
- Presence of lymphedema of the lower limbs
- Contraindication to radiomarkers (allergy or hypersensitivity to any component of the biomarker)
- Patient with dementia or altered mental status
- Pregnant or breast feeding patients
- Participation in any other clinical trial that could interfere with the study results
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: isotopic intraoperative detection
Lower-limb drainage isotopic intraoperative detection
|
A radiopharmaceutical is injected into both feet on the day before surgery.
Pelvic lower-limb drainage nodes (LLDNs) are identified using preoperative SPECT-CT and intraoperative isotopic probe detection, and then electively removed before complete pelvic lymphadenectomy.
LLDNs and pelvic lymphadenectomy specimens undergo separate histological analysis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Lower-limb drainage intraoperative isotopic detection rate in patients with pelvic lymphadenectomy for gynaecological cancers.
Time Frame: day of surgery
|
day of surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Anatomy of lower-limb drainage
Time Frame: day of surgery
|
day of surgery
|
|
Percentage of patients with metastatic lower limb sampling
Time Frame: 2 weeks after surgery
|
2 weeks after surgery
|
|
Follow-up of patients to identify complications, and namely lower-limb lymphedema.
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Anne-Sophie BATS, MD, PhD, Assistance Publique des Hopitaux de Paris
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2013
Primary Completion (Actual)
June 4, 2021
Study Completion (Actual)
June 4, 2021
Study Registration Dates
First Submitted
September 17, 2013
First Submitted That Met QC Criteria
September 17, 2013
First Posted (Estimate)
September 19, 2013
Study Record Updates
Last Update Posted (Estimate)
January 9, 2023
Last Update Submitted That Met QC Criteria
January 6, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P110903
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.