Lower-Limb Drainage Mapping in Pelvic Lymphadenectomy for Gynaecological Cancer

Phase 4

Completed

• Conditions: Gynaecological Malignant Tumours With Indication of Pelvic Lymphadenectomy
• Interventions: Procedure: Lower-limb drainage isotopic intraoperative detection

• Registration Number: NCT01946672
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-09-17
• Study First Submitted QC: 2013-09-17
• Study First Posted: 2013-09-19
• Primary Completion: 2021-06-04
• Study Completion: 2021-06-04
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-06
• Last Update Posted: 2023-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
isotopic intraoperative detection	Lower-limb drainage isotopic intraoperative detection	Lower-limb drainage isotopic intraoperative detection

Primary Outcome Measures

Name	Time	Method
Lower-limb drainage intraoperative isotopic detection rate in patients with pelvic lymphadenectomy for gynaecological cancers.	day of surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

HEGP; 🇫🇷 Paris, Ile-de-France, France