Lower-Limb Drainage Mapping in Pelvic Lymphadenectomy for Gynaecological Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Individualisation du Drainage Lymphatique Des Membres inférieurs Lors du Curage Pelvien Pour Cancer gynécologique

Conditions
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Gynaecological Malignant Tumours With Indication of Pelvic Lymphadenectomy

Intervention / Treatment
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* Procedure: Lower-limb drainage isotopic intraoperative detection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: isotopic intraoperative detection<br>Lower-limb drainage isotopic intraoperative detection | Procedure: Lower-limb drainage isotopic intraoperative detection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower-limb drainage intraoperative isotopic detection rate in patients with pelvic lymphadenectomy for gynaecological cancers. |  | day of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomy of lower-limb drainage |  | day of surgery | 
| Percentage of patients with metastatic lower limb sampling |  | 2 weeks after surgery | 
| Follow-up of patients to identify complications, and namely lower-limb lymphedema. |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gynaecological malignancy, pelvic lymphadenectomy, lymphedema, sentinel node, reverse mapping