Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sentinel Lymph Node Navigation Surgery Using Near-infrared Indocyanine Green Imaging in Early Esophageal Cancer

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04173676
Recruitment Status : Recruiting
First Posted : November 22, 2019
Last Update Posted : November 22, 2019
Sponsor:
Collaborator:
Sun Yat-sen University
Information provided by (Responsible Party):
Fifth Affiliated Hospital, Sun Yat-Sen University

Brief Summary:

The esophageal squamous cell carcinoma (ESCC) has high prevalence and mortality in China, which become a severe challenge for public health. Esophagectomy is the preferred choice for the patients who are diagnosed with ESCC in early stage .Although three-field lymphadenectomy has improved patient survival and reduced tumor recurrence, Surgery-related complications increased dramatically.

It has become a research hotspot to find an effective detection method to identify the lymph node metastasis of ESCC and avoid ineffective expanded lymphadenectomy .The molecular imaging technology has been developed for intra-operative visualization and precise resection of the tumors.

Indocyanine Green for Injection (ICG) has been used as a contrast agent in the near-infrared imaging system for the surgical navigation technology, which has a relatively positive effect in the clinical application of gastric cancer and liver cancer.There are few reports on the application of ICG near-infrared imaging tracer lymph nodes in the surgery of ESCC. This study intends to identify the detection rate of sentinel lymph node (SLN) and determine the accuracy of regional lymph node metastasis in ESCC by ICG near-infrared imaging technique, which provides clinical evidence for subsequent precise resection of the lymph nodes.

This will be a single-center and one-arm prospective trial. The ESCC patients will be recruited with strict criteria. 50 patients will be enrolled between18 and 75 years old, without gender limit. The submucosal injection of ICG will be performed preoperatively by gastroscopy on the upper edge of the esophageal tumor. NIR fluorescence imaging will be performed intraoperatively to observe the lymph nodes. The luminescent lymph node is defined as SLN. According to the standard procedure, 3 field lymphadenectomy will be performed, and all the resected lymph nodes will be subjected to pathological analysis including correlation study of fluorescence signal and tumor tissue in pathology slice.

This clinical trial is anticipated to evaluate the detection rate of SLN in ESCC with ICG near-infrared fluorescence imaging and determine the accuracy of regional lymph node metastasis.


Condition or disease Intervention/treatment Phase
Detection Rate of SLN ; Accuracy Rate of Lymph Node Metastasis Drug: Indocyanine Green for Injection Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 155 participants
Intervention Model: Single Group Assignment
Intervention Model Description: The sentinel lymph nodes are observed by submucosal injection of ICG
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Sentinel Lymph Node Navigation Using Near-infrared Indocyanine Green Imaging in Radical Esophagectomy of Single-Port Inflatable Mediastinoscopy Combined With Laparoscopy Surgery :a Single-arm Clinical Trial
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: use of indocyanine green
submucosal injection of ICG is by gastroscopy on the upper edge of the esophageal tumor,Dose of 0.5mg
Drug: Indocyanine Green for Injection
The sentinel lymph nodes were observed by submucosal injection of ICG




Primary Outcome Measures :
  1. the detection rate of sentinel lymph node [ Time Frame: through study completion, an average of 1 year ]
    the detection rate of sentinel lymph node in all the enrolled patients

  2. The positive rate of sentinel lymph node [ Time Frame: through study completion, an average of 1 year ]
    the positive rate of sentinel lymph node in all the enrolled patients



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 to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years old ≤ age ≤ 75 years old, gender is not limited;
  2. patient who is diagnosed with ESCC and choose to proceed with surgery
  3. patient with cTNM stage:T1-3N0-1M0
  4. tumor located at the middle thoracic or lower thoracic esophagus
  5. The main organ function is basically normal: Karnofsky score >70%;
  6. Laboratory blood tests meet surgical standards;

Exclusion Criteria:

  1. pregnancy or breastfeeding
  2. history of iodide or seafood allergy,
  3. Patient with occult metastatic disease at the time of surgery
  4. patient with mental disorder;
  5. Patient who is simultaneously involved in another clinical trial;

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): NCT04173676


Contacts
Layout table for location contacts
Contact: Hong Shan, PhD +86-18826913336 shanhong@mail.sysu.edu.cn

Locations
Layout table for location information
China, Guangdong
The Fifth Affiliated Hospital of Sun Yat-sen University Recruiting
Zhuhai, Guangdong, China, 519000
Contact: Xiaojin Wang, MD    +86-13798967219    wangxj55@mail.sysu.edu.cn   
Sponsors and Collaborators
Fifth Affiliated Hospital, Sun Yat-Sen University
Sun Yat-sen University

Publications of Results:

Layout table for additonal information
Responsible Party: Fifth Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT04173676     History of Changes
Other Study ID Numbers: MIC-ESO-002
First Posted: November 22, 2019    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes