Lower-Limb Drainage Mapping in Pelvic Lymphadenectomy for Gynaecological Cancer

NCT ID: NCT01946672

Last Updated: 2023-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2021-06-04

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.

Conditions

Gynaecological Malignant Tumours With Indication of Pelvic Lymphadenectomy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

isotopic intraoperative detection

Lower-limb drainage isotopic intraoperative detection

Group Type: EXPERIMENTAL

Lower-limb drainage isotopic intraoperative detection

Intervention Type: 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.

Interventions

Lower-limb drainage isotopic intraoperative detection

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne-Sophie BATS, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

assistance publique des hopitaux de paris

Locations

HEGP

Paris, Île-de-France Region, France

Countries

France

Other Identifiers

P110903

Identifier Type: -

Identifier Source: org_study_id