Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Lower-Limb Drainage Mapping in Pelvic Lymphadenectomy for Gynaecological Cancer (SENTIJAMBE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01946672
Recruitment Status : Unknown
Verified December 2017 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Active, not recruiting
First Posted : September 19, 2013
Last Update Posted : December 21, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Gynaecological Malignant Tumours With Indication of Pelvic Lymphadenectomy Procedure: Lower-limb drainage isotopic intraoperative detection Phase 4

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Individualisation du Drainage Lymphatique Des Membres inférieurs Lors du Curage Pelvien Pour Cancer gynécologique
Study Start Date : July 2013
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: isotopic intraoperative detection
Lower-limb drainage isotopic intraoperative detection
 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Lower-limb drainage intraoperative isotopic detection rate in patients with pelvic lymphadenectomy for gynaecological cancers. [ Time Frame: day of surgery ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01946672


Locations
Layout table for location information
France
HEGP
Paris, Ile-de-France, France, 75
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Principal Investigator: Anne-Sophie BATS, MD, PhD assistance publique des hopitaux de paris
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01946672    
Other Study ID Numbers: P110903
First Posted: September 19, 2013    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017
Keywords provided by Assistance Publique - Hôpitaux de Paris:
gynaecological malignancy
pelvic lymphadenectomy
lymphedema
sentinel node
reverse mapping
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms