The Role of Indocyanine Green to Identify Sentinel Lymph Node in Uterine Cancer

NCT02822833 | Unknown DMC

• 1 other identifier: 04
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Endometrial cancer is the most common gynecologic malignancy in developed countries and the second one in developing countries following cervical cancer. The primary treatment for endometrial cancer involves total hysterectomy and bilateral salpingo-oophorectomy, with adjuvant radiotherapy and/or chemotherapy reserved for patients with advanced disease or who have risk factors for relapse. The tumor is confined to the uterus in 85% of endometrial cancers. Hence, it's controversial to perform systematic lymphadenectomy to all patients. The primary purpose of the present study is the to investigate the feasibility of sentinel lymph node determination in endometrial cancer patients operated via conventional laparoscopy. To determine sentinel lymph nodes cervical indocyanine green will be injected prior to the surgery. During the surgery using fluorescent imaging systems sentinel lymph nodes will be removed and examined by frozen section. Afterwards, systematic pelvic lymphadenectomy will be performed. In case of type II endometrial cancer, grade 3, metastatic sentinel lymph nodes or macroscopically enlarged paraaortic lymph nodes, paraaortic lymphadenectomy will also be performed. The secondary purpose of the study is to compare the conventional laparoscopy in sentinel lymph node mapping of endometrial cancer patients.

Conditions

Endometrial Neoplasm

Outcome Measures

Primary Outcomes (2)

• Sensitivity and specificity of sentinel lymph node frozen section

  6 months

• Unilateral or bilateral sentinel lymph node detection rate by indocyanine green

  6 months

Secondary Outcomes (1)

• Negative and positive predictive values for sentinel lymph node frozen section

  6 months

Study Arms (1)

Sentinel lymph node mapping

EXPERIMENTAL

Sentinel lymph node mapping with indocyanine green injection to cervix in endometrial cancer patients operated laparoscopically

Procedure: Sentinel lymph node mapping

Interventions

Sentinel lymph node mapping PROCEDURE

Before laparoscopic hysterectomy and lymphadenectomy procedure for endometrial cancer, Indocyanine green solution will be injected through cervix. Then the surgeon will look for sentinel lymph nodes under fluorescence visualization.

Also known as: Karl Storz ICG system, to visualize the fluorescence, Indocyanine green, PULSION medical systems

Sentinel lymph node mapping

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologic diagnosis of endometrial cancer
• Clinical stage I or II

You may not qualify if:

• Contraindications for operation (hematological or coagulation disorders)
• Advanced stage
• Pregnancy or puerperium
• Fertility preserving surgery

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University School of Medicine Department of Ob&Gyn

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Salih Taşkın, Assoc. Prof.

CONTACT

+903125956405; salihtaskin@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: July 4, 2016
• Study Start: July 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: September 13, 2016

Record last verified: 2016-09

Locations

TU (1)