Clinical trial NCT01946672: Lower-Limb Drainage Mapping in Pelvic Lymphadenectomy for Gynaecological Cancer
Official title: Individualisation du Drainage Lymphatique Des Membres inférieurs Lors du Curage Pelvien Pour Cancer gynécologique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gynaecological Malignant Tumours With Indication of Pelvic Lymphadenectomy
Keywords: gynaecological malignancy
pelvic lymphadenectomy
lymphedema
sentinel node
reverse mapping
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-09-19
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lower-limb drainage intraoperative isotopic detection rate in patients with pelvic lymphadenectomy for gynaecological cancers.
timeFrame: day of surgery
Secondary outcomes:
measure: Anatomy of lower-limb drainage
timeFrame: day of surgery
measure: Percentage of patients with metastatic lower limb sampling
timeFrame: 2 weeks after surgery
measure: Follow-up of patients to identify complications, and namely lower-limb lymphedema.
timeFrame: 5 years
Other outcomes:
Locations:
city: Paris
country: France
facility: HEGP
state: Ile-de-France
Study officials:
affiliation: assistance publique des hopitaux de paris
name: Anne-Sophie BATS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: