Lower-Limb Drainage Mapping in Pelvic Lymphadenectomy for Gynaecological Cancer

Gynaecological Malignant Tumours With Indication of Pelvic Lymphadenectomy Clinical Trial

— SENTIJAMBE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01946672
• Other study ID #: P110903
• Status: Completed
• Phase: Phase 4
• Start date: July 2013
• Est. completion date: June 4, 2021

Study information

• Verified date: January 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 4, 2021
• Est. primary completion date: June 4, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gynaecological Malignant Tumours With Indication of Pelvic Lymphadenectomy
• Neoplasms

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
France	HEGP	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower-limb drainage intraoperative isotopic detection rate in patients with pelvic lymphadenectomy for gynaecological cancers.		day of surgery
Secondary	Anatomy of lower-limb drainage		day of surgery
Secondary	Percentage of patients with metastatic lower limb sampling		2 weeks after surgery
Secondary	Follow-up of patients to identify complications, and namely lower-limb lymphedema.		5 years