Sentinel Lymph Node Mapping In Cervical Cancer

Summary

Lymph node assessment provides the crucial information about the prognosis of cervical cancer. Sentinel lymph node stands in the first station on the lymph node metastasis pathways. While traditional systemically lymph node resection would bring a lot of complications, sentinel node mapping and biopsy is a feasible way with less damage to evaluate whether lymph node metastasis occurs in early cervical cancer patients, due to less lymph nodes resected. However, the process of this technology isn't well established. The investigators intend to conduct a prospective and multicentric study to evaluate the effectiveness of different mapping methods to achieve a reliable lymph node assessment. Early cervical cancer patients in each center will be recruited in the investigators' study with inclusion and exclusion criteria. After the patients signing the informed consent form, the surgery process will be performed, including sentinel lymph node mapping with Carbon Nanoparticles (CNP) or CNP combining Indocyanine Green(ICG), extra-fascial/sub-extensive/extensive hysterectomy, pelvic with or without para-aortic lymph node resection, sequentially. All resected nodes will be pathologically exanimated. Then the data obtained will be analyzed and discussed deeply and finally lead to a conclusion.

Conditions

• Uterine Cervical Neoplasms

Interventions

PROCEDURE

sentinel lymph node biopsy

1. Injecting carbon nanoparticles (CNP)\[Not Equipped with near-infrared fluorescent vascular imager\] or CNP combining Indocyanine Green(ICG)\[Equipped with near-infrared fluorescent vascular imager\]. 2. Identifying and removing sentinel lymph nodes. 3. Staining all nodes using hematoxylin-eosin staining.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences

  collaborator OTHER

• Peking University International Hospital

  collaborator OTHER

• Shanghai First Maternity and Infant Hospital

  collaborator OTHER

• Obstetrics & Gynecology Hospital of Fudan University

  collaborator OTHER

• Sun Yat-sen University

  collaborator OTHER

• Tianjin Central Hospital of Gynecology Obstetrics

  collaborator OTHER

• Cancer Hospital of Guangxi Medical University

  collaborator OTHER

• First People's Hospital of Foshan

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Second Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Beijing Blue Sky Shared Health Management Co., Ltd.

  collaborator UNKNOWN

• Chongqing Lummy Pharmaceutical Co.,Ltd.

  collaborator UNKNOWN

• Peking University People's Hospital

  lead OTHER

Principal Investigators

• Jianliu Wang, Professor · Peking University People's Hospital

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-12-15

Primary Completion

2020-06-30

Completion

2020-06-30

Countries

• China

Study Locations