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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| isotopic intraoperative detection | Experimental | Lower-limb drainage isotopic intraoperative detection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lower-limb drainage isotopic intraoperative detection | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Lower-limb drainage intraoperative isotopic detection rate in patients with pelvic lymphadenectomy for gynaecological cancers. | day of surgery |
| 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. |
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Inclusion Criteria:
Female patients 18 years of age or older with indication of pelvic lymphadenectomy for gynaecological malignancy:
Must provide her signed and informed consent
Beneficiary of a health insurance
Having received a medical examination
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne-Sophie BATS, MD, PhD | assistance publique des hopitaux de paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HEGP | Paris | Île-de-France Region | 75 | France |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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|
| 5 years |