Gynaecological Malignant Tumours With Indication of Pelvic Lymphadenectomy
Conditions
Keywords
gynaecological malignancy, pelvic lymphadenectomy, lymphedema, sentinel node, reverse mapping
Brief summary
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.
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.
Interventions
PROCEDURELower-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.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lower-limb drainage intraoperative isotopic detection rate in patients with pelvic lymphadenectomy for gynaecological cancers. | day of surgery |
Secondary
| Measure | Time frame |
|---|---|
| Follow-up of patients to identify complications, and namely lower-limb lymphedema. | 5 years |
| Anatomy of lower-limb drainage | day of surgery |
| Percentage of patients with metastatic lower limb sampling | 2 weeks after surgery |
Countries
France
Outcome results
None listed