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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01946672
First received: September 17, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Individualisation du Drainage Lymphatique Des Membres inférieurs Lors du Curage Pelvien Pour Cancer gynécologique

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Lower-limb drainage intraoperative isotopic detection rate in patients with pelvic lymphadenectomy for gynaecological cancers. [ Time Frame: day of surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anatomy of lower-limb drainage [ Time Frame: day of surgery ] [ Designated as safety issue: No ]
  • Percentage of patients with metastatic lower limb sampling [ Time Frame: 2 weeks after surgery ] [ Designated as safety issue: No ]
  • Follow-up of patients to identify complications, and namely lower-limb lymphedema. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 55
Study Start Date: July 2013
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01946672

Contacts
Contact: Anne-Sophie BATS, MD, PhD +33156093586 anne-sophie.bats@egp.aphp.fr
Contact: Anne-Sophie BATS, MD, PhD +33156093586 anne-spphie.bats@egp.aphp.fr

Locations
France
HEGP Recruiting
Paris, Ile-de-France, France, 75
Contact: Anne-Sophie BATS, MD, PhD    +33156093586    anne-sophie.bats@egp.aphp.fr   
Contact: Gilles CHATELLIER, MD, PhD    +33156093020    gilles.chatellier@egp.aphp.fr   
Principal Investigator: Anne-Sophie BATS, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Anne-Sophie BATS, MD, PhD assistance publique des hopitaux de paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01946672     History of Changes
Other Study ID Numbers: P110903
Study First Received: September 17, 2013
Last Updated: September 17, 2013
Health Authority: France: Committee for the Protection of Personnes

Keywords provided by Assistance Publique - Hôpitaux de Paris:
gynaecological malignancy
pelvic lymphadenectomy
lymphedema
sentinel node
reverse mapping

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on October 20, 2014