Lower-Limb Drainage Mapping in Pelvic Lymphadenectomy for Gynaecological Cancer (SENTIJAMBE)

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 4

Conditions: Gynaecological Malignant Tumours With Indication of Pelvic Lymphadenectomy

Treatments: Procedure: Lower-limb drainage isotopic intraoperative detection

Study type: Interventional

Funder types: Other

Identifiers

NCT01946672

P110903

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

isotopic intraoperative detection

Experimental group

Description:

Lower-limb drainage isotopic intraoperative detection

Treatment:

Procedure: Lower-limb drainage isotopic intraoperative detection