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

NCT ID: NCT02822833

Last Updated: 2016-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-06-30

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

Study Design

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

Study Groups

Sentinel lymph node mapping

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

Group Type: EXPERIMENTAL

Sentinel lymph node mapping

Intervention Type: 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.

Interventions

Sentinel lymph node mapping

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.

Intervention Type: PROCEDURE

Other Intervention Names

Karl Storz ICG system, to visualize the fluorescence; Indocyanine green, PULSION medical systems

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

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

Sponsors

Ankara University

OTHER

Sponsor Role: lead

Responsible Party

salih taskin

Assoc. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara University School of Medicine Department of Ob&Gyn

Ankara, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Salih Taşkın, Assoc. Prof.

Role: CONTACT

salihtaskin@yahoo.com

+903125956405

Facility Contacts

Salih Taşkın, Assoc. Prof.

Role: primary

salihtaskin@yahoo.com

+903125956405

Other Identifiers

04

Identifier Type: -

Identifier Source: org_study_id