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Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection (ICGTinLG)

Primary Purpose

Stomach Neoplasms, Indocyanine Green

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Indocyanine Green Tracer
Sponsored by
Fujian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Neoplasms focused on measuring Stomach Neoplasms, Indocyanine Green Tracer, Laparoscopic Gastrectomy, Lymph Node Dissection

Eligibility Criteria

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

Inclusion Criteria:

  • Age from 18 to 75 years
  • Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
  • clinical stage tumor 1-4a (cT1-4a), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
  • No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations
  • Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
  • American Society of Anesthesiology score (ASA) class I, II, or III
  • Written informed consent

Exclusion Criteria:

  • Women during pregnancy or breast-feeding
  • Severe mental disorder
  • History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
  • History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
  • Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
  • History of other malignant disease within past five years
  • History of previous neoadjuvant chemotherapy or radiotherapy
  • History of unstable angina or myocardial infarction within past six months
  • History of cerebrovascular accident within past six months
  • History of continuous systematic administration of corticosteroids within one month
  • Requirement of simultaneous surgery for other disease
  • Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  • FEV1<50% of predicted values
  • Diffuse; widespread; plastica

Sites / Locations

  • Fujian Medical University Union Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Indocyanine Green Tracer

No Indocyanine Green Tracer

Arm Description

Indocyanine Green Tracer will be used in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma in this group.

Indocyanine Green Tracer will not be used in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma in this group.

Outcomes

Primary Outcome Measures

Total Number of Retrieved Lymph Nodes
Compare total number of retrieved lymph nodes in both group.

Secondary Outcome Measures

The rate of fluorescence
The number of fluorescent lymph node in experimental group is divided by the total number of lymph nodes in active experimental group
Positive rate
The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in experimental group
False positive rate
The number of negative lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in experimental group
Negative rate
The number of negative lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in experimental group
False negative rate
The number of positive lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in experimental group
Number of Metastasis Lymph Nodes
Compare number of positive lymph nodes in both group.
Metastasis rate of lymph node
Compare metastasis rate of lymph node in both group
Morbidity and mortality rates
This is for the early postoperative complication and mortality, which defined as the event observed within 30 days after surgery.
3-year disease free survival rate
disease-free survival was defined as the time from surgery to the time of recurrence or death from any cause
3-year recurrence pattern
Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.
Postoperative recovery course
Time to first ambulation, flatus, liquid diet and soft diet, duration of postoperative hospital stay and postoperative pain are used to assess the postoperative recovery course.Visual analog pain score method is used to evaluate the difference of postoperative pain degree.
Operation time
The variation of weight
The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
Intraoperative blood loss
Conversive rate
Intraoperative morbidity rates
The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
Incision length
The variation of cholesterol
The variation of cholesterol in millimole/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
The variation of album
The variation of album in gram/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
The results of endoscopy
The incidence of reflux esophagitis under the endoscopy on postoperative 3 and 12 months are used to access the postoperative quality of life.
The variation of body temperature
The daily highest body temperature in degree centigrade before discharge are recorded to access the inflammatory and immune response.
The variation of white blood cell count
The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
The variation of hemoglobin
The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
The variation of C-reactive protein
The values of C-reactive protein IN milligram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
The variation of prealbumin
The values of prealbumin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
3-year overall survival rate
Overall survival was defined as the time from surgery to death from any cause

Full Information

First Posted
January 13, 2017
Last Updated
June 1, 2022
Sponsor
Fujian Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03050879
Brief Title
Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection
Acronym
ICGTinLG
Official Title
Prospective Randomized Controlled Trials on Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 15, 2017 (Actual)
Primary Completion Date
July 13, 2019 (Actual)
Study Completion Date
July 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fujian Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to explore the clinical outcomes of Indocyanine Green Tracer using in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma（cT1-4a, N-/+, M0）.
Detailed Description
Indocyanine Green Tracer is often applied in surgery for early gastric adenocarcinoma. Its application in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma is at the stage of cases accumulation, method studying and clinical research. There is no prospective studies to identify the clinical outcomes of Indocyanine Green Tracer using in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma. On the basis of more than 3000 cases of laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma, we want to apply the Indocyanine Green Tracer, a cheap, easy to operate and no radiation pollution way, to predict the positive lymph nodes in gastric adenocarcinoma, to guid the scope of laparoscopic lymph node dissection for gastric adenocarcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms, Indocyanine Green
Keywords
Stomach Neoplasms, Indocyanine Green Tracer, Laparoscopic Gastrectomy, Lymph Node Dissection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
266 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Indocyanine Green Tracer
Arm Type
Experimental
Arm Description
Indocyanine Green Tracer will be used in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma in this group.
Arm Title
No Indocyanine Green Tracer
Arm Type
Active Comparator
Arm Description
Indocyanine Green Tracer will not be used in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma in this group.
Intervention Type
Drug
Intervention Name(s)
Indocyanine Green Tracer
Other Intervention Name(s)
ICG
Intervention Description
Laparoscopic gastrectomy with lymph node dissection for gastric cancer using Indocyanine Green Tracer
Primary Outcome Measure Information:
Title
Total Number of Retrieved Lymph Nodes
Description
Compare total number of retrieved lymph nodes in both group.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
The rate of fluorescence
Description
The number of fluorescent lymph node in experimental group is divided by the total number of lymph nodes in active experimental group
Time Frame
14 days
Title
Positive rate
Description
The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in experimental group
Time Frame
14 days
Title
False positive rate
Description
The number of negative lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in experimental group
Time Frame
14 days
Title
Negative rate
Description
The number of negative lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in experimental group
Time Frame
14 days
Title
False negative rate
Description
The number of positive lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in experimental group
Time Frame
14 days
Title
Number of Metastasis Lymph Nodes
Description
Compare number of positive lymph nodes in both group.
Time Frame
14 days
Title
Metastasis rate of lymph node
Description
Compare metastasis rate of lymph node in both group
Time Frame
14 days
Title
Morbidity and mortality rates
Description
This is for the early postoperative complication and mortality, which defined as the event observed within 30 days after surgery.
Time Frame
30 days
Title
3-year disease free survival rate
Description
disease-free survival was defined as the time from surgery to the time of recurrence or death from any cause
Time Frame
36 months
Title
3-year recurrence pattern
Description
Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.
Time Frame
36 months
Title
Postoperative recovery course
Description
Time to first ambulation, flatus, liquid diet and soft diet, duration of postoperative hospital stay and postoperative pain are used to assess the postoperative recovery course.Visual analog pain score method is used to evaluate the difference of postoperative pain degree.
Time Frame
10 days
Title
Operation time
Time Frame
1 day
Title
The variation of weight
Description
The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
Time Frame
3, 6, 9 and 12 months
Title
Intraoperative blood loss
Time Frame
1 day
Title
Conversive rate
Time Frame
1 day
Title
Intraoperative morbidity rates
Description
The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
Time Frame
1 day
Title
Incision length
Time Frame
1 day
Title
The variation of cholesterol
Description
The variation of cholesterol in millimole/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
Time Frame
3, 6, 9 and 12 months
Title
The variation of album
Description
The variation of album in gram/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
Time Frame
3, 6, 9 and 12 months
Title
The results of endoscopy
Description
The incidence of reflux esophagitis under the endoscopy on postoperative 3 and 12 months are used to access the postoperative quality of life.
Time Frame
3, 6, 9 and 12 months
Title
The variation of body temperature
Description
The daily highest body temperature in degree centigrade before discharge are recorded to access the inflammatory and immune response.
Time Frame
8 days
Title
The variation of white blood cell count
Description
The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
Time Frame
Preoperative 3 days and postoperative 1, 3, and 5 days
Title
The variation of hemoglobin
Description
The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
Time Frame
Preoperative 3 days and postoperative 1, 3, and 5 days
Title
The variation of C-reactive protein
Description
The values of C-reactive protein IN milligram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
Time Frame
Preoperative 3 days and postoperative 1, 3, and 5 days
Title
The variation of prealbumin
Description
The values of prealbumin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
Time Frame
Preoperative 3 days and postoperative 1, 3, and 5 days
Title
3-year overall survival rate
Description
Overall survival was defined as the time from surgery to death from any cause
Time Frame
36 months

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 from 18 to 75 years Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy clinical stage tumor 1-4a (cT1-4a), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG) American Society of Anesthesiology score (ASA) class I, II, or III Written informed consent Exclusion Criteria: Women during pregnancy or breast-feeding Severe mental disorder History of previous upper abdominal surgery (except laparoscopic cholecystectomy) History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging History of other malignant disease within past five years History of previous neoadjuvant chemotherapy or radiotherapy History of unstable angina or myocardial infarction within past six months History of cerebrovascular accident within past six months History of continuous systematic administration of corticosteroids within one month Requirement of simultaneous surgery for other disease Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer FEV1<50% of predicted values Diffuse; widespread; plastica
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Changming Huang, Professor
Organizational Affiliation
Fujian Medical University Union Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32101269
Citation
Chen QY, Xie JW, Zhong Q, Wang JB, Lin JX, Lu J, Cao LL, Lin M, Tu RH, Huang ZN, Lin JL, Zheng HL, Li P, Zheng CH, Huang CM. Safety and Efficacy of Indocyanine Green Tracer-Guided Lymph Node Dissection During Laparoscopic Radical Gastrectomy in Patients With Gastric Cancer: A Randomized Clinical Trial. JAMA Surg. 2020 Apr 1;155(4):300-311. doi: 10.1001/jamasurg.2019.6033.
Results Reference
derived

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Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection

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