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Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Remnant Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Recruiting
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 Gastric Cancer focused on measuring Indocyanine Green Tracer, Laparoscopic Gastrectomy, Remnant Gastric Cancer

Eligibility Criteria

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

Inclusion Criteria: Age from 18 to 75 years Remnant gastric cancer (cT1-4a, N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition) (4) No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations (5) Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale (6) ASA (American Society of Anesthesiology) class I to III (7) Written informed consent Exclusion Criteria: Women during pregnancy or breast-feeding Severe mental disorder History of previous upper abdominal surgery (except for laparoscopic cholecystectomy and gastrectomy) History of previous gastric surgery (including ESD/EMR for gastric cancer) Rejection of laparoscopic resection History of allergy to iodine agents 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 the past six months History of unstable angina or myocardial infarction within past six months History of continuous systematic administration of corticosteroids within one month Requirement of simultaneous surgery for another disease Emergency surgery due to complications (bleeding, obstruction or perforation) caused by gastric cancer FEV1<50% of the predicted values Linitis plastica, Widespread

Sites / Locations

  • Fujian Medical University Union HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ICG

Non-ICG

Arm Description

Laparoscopic gastrectomy Group with the use of near-infrared imaging (ICG group)

Laparoscopic gastrectomy Group without the use of near-infrared imaging (Non-ICG group)

Outcomes

Primary Outcome Measures

Total Number of Retrieved Lymph Nodes
Total Number of Retrieved Lymph Nodes

Secondary Outcome Measures

Lymph node noncompliance rate
Lymph node noncompliance rate
Relationship between fluorescent lymph nodes in the ICG group and total number of lymph nodes in the ICG group
Relationship between fluorescent lymph nodes in the ICG group and total number of lymph nodes in the ICG group
Relationship between fluorescent lymph nodes in the ICG group and positive lymph nodes in the ICG group (positive rate)
Relationship between fluorescent lymph nodes in the ICG group and positive lymph nodes in the ICG group (positive rate)
Relationship between fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (false positive rate)
Relationship between fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (false positive rate)
Relationship between non-fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (negative rate)
Relationship between non-fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (negative rate)
Number of Metastasis Lymph Nodes
Number of Metastasis Lymph Nodes
Metastasis rate of lymph node
Metastasis rate of lymph node
Postoperative morbidity rate
Postoperative morbidity rate
Postoperative mortality rate
Postoperative mortality rate
3-year overall survival rate
3-year overall survival rate
3-year disease-free survival rate
3-year disease-free survival rate
3-year recurrence pattern
3-year recurrence pattern
Postoperative recovery course
Time to first ambulation, flatus, liquid diet and soft diet, and postoperative hospital stay
Intraoperative situation
Operation time, intraoperative blood loss, and intraoperative morbidity rate

Full Information

First Posted
June 3, 2022
Last Updated
November 9, 2022
Sponsor
Fujian Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05618821
Brief Title
Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Remnant Gastric Cancer
Official Title
Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Remnant Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 3, 2022 (Actual)
Primary Completion Date
April 1, 2025 (Anticipated)
Study Completion Date
April 1, 2028 (Anticipated)

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

5. Study Description

Brief Summary
Patients with resectable remnant gastric cancer were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in guiding laparoscopic lymph node dissection for remnant gastric cancer by comparing injection ICG group and non-injection ICG group.
Detailed Description
Indocyanine Green Tracer is often applied in surgery for gastric cancer. Its application in laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer 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 remnant gastric cancer. On the basis of more than 300 cases of laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer, 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 remnant gastric cancer, to guid the scope of laparoscopic lymph node dissection for remnant gastric cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Indocyanine Green Tracer, Laparoscopic Gastrectomy, Remnant Gastric Cancer

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
ICG
Arm Type
Experimental
Arm Description
Laparoscopic gastrectomy Group with the use of near-infrared imaging (ICG group)
Arm Title
Non-ICG
Arm Type
Active Comparator
Arm Description
Laparoscopic gastrectomy Group without the use of near-infrared imaging (Non-ICG group)
Intervention Type
Drug
Intervention Name(s)
Indocyanine Green Tracer
Intervention Description
Laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer using Indocyanine Green Tracer
Primary Outcome Measure Information:
Title
Total Number of Retrieved Lymph Nodes
Description
Total Number of Retrieved Lymph Nodes
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Lymph node noncompliance rate
Description
Lymph node noncompliance rate
Time Frame
30 days
Title
Relationship between fluorescent lymph nodes in the ICG group and total number of lymph nodes in the ICG group
Description
Relationship between fluorescent lymph nodes in the ICG group and total number of lymph nodes in the ICG group
Time Frame
30 days
Title
Relationship between fluorescent lymph nodes in the ICG group and positive lymph nodes in the ICG group (positive rate)
Description
Relationship between fluorescent lymph nodes in the ICG group and positive lymph nodes in the ICG group (positive rate)
Time Frame
30 days
Title
Relationship between fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (false positive rate)
Description
Relationship between fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (false positive rate)
Time Frame
30 days
Title
Relationship between non-fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (negative rate)
Description
Relationship between non-fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (negative rate)
Time Frame
30 days
Title
Number of Metastasis Lymph Nodes
Description
Number of Metastasis Lymph Nodes
Time Frame
30 days
Title
Metastasis rate of lymph node
Description
Metastasis rate of lymph node
Time Frame
30 days
Title
Postoperative morbidity rate
Description
Postoperative morbidity rate
Time Frame
30 days
Title
Postoperative mortality rate
Description
Postoperative mortality rate
Time Frame
30 days
Title
3-year overall survival rate
Description
3-year overall survival rate
Time Frame
3 years
Title
3-year disease-free survival rate
Description
3-year disease-free survival rate
Time Frame
3 years
Title
3-year recurrence pattern
Description
3-year recurrence pattern
Time Frame
3 years
Title
Postoperative recovery course
Description
Time to first ambulation, flatus, liquid diet and soft diet, and postoperative hospital stay
Time Frame
30 days
Title
Intraoperative situation
Description
Operation time, intraoperative blood loss, and intraoperative morbidity rate
Time Frame
30 days

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 Remnant gastric cancer (cT1-4a, N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition) (4) No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations (5) Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale (6) ASA (American Society of Anesthesiology) class I to III (7) Written informed consent Exclusion Criteria: Women during pregnancy or breast-feeding Severe mental disorder History of previous upper abdominal surgery (except for laparoscopic cholecystectomy and gastrectomy) History of previous gastric surgery (including ESD/EMR for gastric cancer) Rejection of laparoscopic resection History of allergy to iodine agents 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 the past six months History of unstable angina or myocardial infarction within past six months History of continuous systematic administration of corticosteroids within one month Requirement of simultaneous surgery for another disease Emergency surgery due to complications (bleeding, obstruction or perforation) caused by gastric cancer FEV1<50% of the predicted values Linitis plastica, Widespread
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hualong Zheng
Phone
+8618359190587
Email
291167038@qq.com
Facility Information:
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hualong Zheng
Phone
+8618359190587
Email
291167038@qq.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Remnant Gastric Cancer

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