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

Phase 1

• Conditions: Detection Rate of SLN ; Accuracy Rate of Lymph Node Metastasis
• Interventions: Drug: Indocyanine Green for Injection

• Registration Number: NCT04173676
• Lead Sponsor: 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 one-arm prospective trial. The ESCC patients will be recruited with strict criteria. 84 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 superior and inferior 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-17
• Study First Submitted QC: 2019-11-21
• Study First Posted: 2019-11-22
• Study Start: 2019-12-02
• Status Verified: 2020-05
• Last Update Submitted: 2021-02-22
• Last Update Posted: 2021-02-24
• Primary Completion: 2021-11-30
• Study Completion: 2021-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
use of indocyanine green	Indocyanine Green for Injection	submucosal injection of ICG is by gastroscopy on the superior and inferior edge of the esophageal tumor,Dose of 0.5mg

Primary Outcome Measures

Name	Time	Method
The positive rate of sentinel lymph node	through study completion, an average of 1 year	the positive rate of sentinel lymph node in all the enrolled patients
the detection rate of sentinel lymph node	through study completion, an average of 1 year	the detection rate of sentinel lymph node in all the enrolled patients

Trial Locations

Locations (1)

The Fifth Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Zhuhai, Guangdong, China