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The Value of Lymph Node Dissection of Indocyanine Green-guided Near-infrared Fluorescent Imaging in Esophagectomy

Primary Purpose

Esophageal Cancer, Indocyanine Green

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Indocyanine green solution
Sponsored by
Fujian Medical University Union Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring Esophageal Cancer, Indocyanine Green, the lymph node markers

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age and gender: 18-75 years old, male and female unlimited;
  2. Preoperative biopsy was pathologically diagnosed as esophageal squamous cell carcinoma;
  3. Preoperative combination with neoadjuvant chemoradiotherapy;
  4. Surgical resection of esophageal carcinoma under endoscopic selection and intraoperative anastomosis;
  5. Heart, lung, liver and kidney functions can tolerate operation;
  6. Patients and their family members can understand and are willing to participate in this clinical study and sign the informed consent.

Exclusion Criteria:

  1. Allergic to ICG or iodine;
  2. Patients with a history of chest surgery or thoracic lymph node dissection;
  3. Patients needing emergency surgery;
  4. Patients whose tumors involve neighboring organs and need to be removed by combining organs;
  5. Patients with tumor recurrence or distant metastasis;
  6. Patients who had participated in or were participating in other clinical trials within the previous 4 weeks were included;
  7. A history of serious mental illness;
  8. Pregnant or lactating women;
  9. Patients with other conditions considered by the researcher should not participate in the study.

Sites / Locations

  • Fujian Medical University Union HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

NIR-ICG

Control

Arm Description

After positioning,Indocyanine green（ICG） dye (Yichuang Pharmaceutical, Liaoning, China) stored at a dose of 25 mg in a small bottle was diluted with 5 ml sterile water. Then, 2 ml of this solution was added to 8 ml sterile water in a dis-posable dressing bowl, resulting in a final concentration of 1.25 mg/ml.

This group of patients received only conventional radical resection of esophageal cancer without Indocyanine green injection.

Outcomes

Primary Outcome Measures

Accuracy rate of lymph node dissection
Accuracy rate of lymph node dissection of each arm（according to postoperative pathology）
False positive rate of lymph node dissection
False positive rate of lymph node dissectionof each arm（according to postoperative pathology）
False negative rate of lymph node dissection
False negative rate of lymph node dissection of each arm（according to postoperative pathology）
Sensitivity and specificity of lymph node dissection
Sensitivity and specificity of lymph node dissection of each arm（according to postoperative pathology）

Secondary Outcome Measures

The mapping of sentinel lymph nodes in esophageal cancer
The mapping of sentinel lymph nodes in esophageal cancer

Full Information

First Posted
October 27, 2020
Last Updated
January 23, 2022
Sponsor
Fujian Medical University Union Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04615806
Brief Title
The Value of Lymph Node Dissection of Indocyanine Green-guided Near-infrared Fluorescent Imaging in Esophagectomy
Official Title
The Value of Lymph Node Dissection of Indocyanine Green-guided Near-infrared Fluorescent Imaging in Video-assisted Thoracoscope Radical Esophagectomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2020 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Medical University Union Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Indocyanine green (ICG) has been recently introduced in clinical practice as a fuorescent tracer. Lymphadenectomy is particularly challenging in esophageal cancer surgery, owing to the complex anatomical drainage.Therefore, the purpose of this study was to explore whether the NIR-ICG imaging system could accurately assess the lymph node markers during radical resection of esophageal cancer.
Detailed Description
This study will be accepted in esophageal cancer patients with Radical Esophag-ectomy as the research object.We will divide them into two groups: experimental group for injection of indocyanine green group and control group for injectable in-docyanine green group.We will compare with the accuracy,false positive rate and false negative rate,sensitivity, specificity and related indicators of intraoperative lymph node cleaning,in order to explore the common position of esophageal cancer sentinel lymph node,guidance of esophageal cancer lymph node cleaning thoroughly.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Indocyanine Green
Keywords
Esophageal Cancer, Indocyanine Green, the lymph node markers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NIR-ICG
Arm Type
Experimental
Arm Description
After positioning,Indocyanine green（ICG） dye (Yichuang Pharmaceutical, Liaoning, China) stored at a dose of 25 mg in a small bottle was diluted with 5 ml sterile water. Then, 2 ml of this solution was added to 8 ml sterile water in a dis-posable dressing bowl, resulting in a final concentration of 1.25 mg/ml.
Arm Title
Control
Arm Type
No Intervention
Arm Description
This group of patients received only conventional radical resection of esophageal cancer without Indocyanine green injection.
Intervention Type
Drug
Intervention Name(s)
Indocyanine green solution
Other Intervention Name(s)
Indocyanine Green for Injection
Intervention Description
ICG solution was endoscopically injected into the esophageal submucosa at the four quadrants around the tumor.
Primary Outcome Measure Information:
Title
Accuracy rate of lymph node dissection
Description
Accuracy rate of lymph node dissection of each arm（according to postoperative pathology）
Time Frame
1 week after operation
Title
False positive rate of lymph node dissection
Description
False positive rate of lymph node dissectionof each arm（according to postoperative pathology）
Time Frame
1 week after operation
Title
False negative rate of lymph node dissection
Description
False negative rate of lymph node dissection of each arm（according to postoperative pathology）
Time Frame
1 week after operation
Title
Sensitivity and specificity of lymph node dissection
Description
Sensitivity and specificity of lymph node dissection of each arm（according to postoperative pathology）
Time Frame
1 week after operation
Secondary Outcome Measure Information:
Title
The mapping of sentinel lymph nodes in esophageal cancer
Description
The mapping of sentinel lymph nodes in esophageal cancer
Time Frame
1 week after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age and gender: 18-75 years old, male and female unlimited; Preoperative biopsy was pathologically diagnosed as esophageal squamous cell carcinoma; Preoperative combination with neoadjuvant chemoradiotherapy; Surgical resection of esophageal carcinoma under endoscopic selection and intraoperative anastomosis; Heart, lung, liver and kidney functions can tolerate operation; Patients and their family members can understand and are willing to participate in this clinical study and sign the informed consent. Exclusion Criteria: Allergic to ICG or iodine; Patients with a history of chest surgery or thoracic lymph node dissection; Patients needing emergency surgery; Patients whose tumors involve neighboring organs and need to be removed by combining organs; Patients with tumor recurrence or distant metastasis; Patients who had participated in or were participating in other clinical trials within the previous 4 weeks were included; A history of serious mental illness; Pregnant or lactating women; Patients with other conditions considered by the researcher should not participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bin Zheng, MD
Phone
13023806690
Email
Dujt1220@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun Chen, MD
Organizational Affiliation
Fujian Medical University Union Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Zheng, MD
Phone
13023806690
Email
Dujt1220@qq.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
35770339
Citation
Du J, Xu G, Yang Z, Zheng B, Chen C. Pericancerous lymph node imaging with indocyanine green-guided near-infrared fluorescence in radical esophagectomy: Protocol for a single-center, prospective, randomized controlled clinical trial. Thorac Cancer. 2022 Aug;13(15):2283-2287. doi: 10.1111/1759-7714.14548. Epub 2022 Jun 29.
Results Reference
derived

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The Value of Lymph Node Dissection of Indocyanine Green-guided Near-infrared Fluorescent Imaging in Esophagectomy

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