Lower-Limb Drainage Mapping in Pelvic Lymphadenectomy for Gynaecological Cancer

Phase 4CompletedNCT01946672

Assistance Publique - Hôpitaux de Paris44 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Gynaecological Malignant Tumours With Indication of Pelvic Lymphadenectomy

Interventions

Lower-limb drainage isotopic intraoperative detectionPROCEDURE

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

HEGP

Paris, Île-de-France Region, France

Outcomes

Primary Outcomes

Lower-limb drainage intraoperative isotopic detection rate in patients with pelvic lymphadenectomy for gynaecological cancers.

Time frame: day of surgery

Secondary Outcomes

Anatomy of lower-limb drainage

Time frame: day of surgery

Percentage of patients with metastatic lower limb sampling

Time frame: 2 weeks after surgery

Follow-up of patients to identify complications, and namely lower-limb lymphedema.

Time frame: 5 years

Data from ClinicalTrials.gov

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