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Completed

NCT Number: NCT01946672

Lower-Limb Drainage Mapping in Pelvic Lymphadenectomy for Gynaecological Cancer

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.

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Key information

Conditions

Gynaecological Malignant Tumours With Indication of Pelvic Lymphadenectomy Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

HEGP

Paris, Île-de-France Region, 75, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: day of surgery

Secondary outcomes

  1. Anatomy of lower-limb drainage

    Time frame: day of surgery

  2. Percentage of patients with metastatic lower limb sampling

    Time frame: 2 weeks after surgery

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

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Individualisation du Drainage Lymphatique Des Membres inférieurs Lors du Curage Pelvien Pour Cancer gynécologique

Acronym: SENTIJAMBE

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
Sep 19, 2013
Registry last updated
Jan 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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