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Indocyanine Green Tracer Using in Laparoscopic Distal Gastrectomy for Early Gastric Cancer

Primary Purpose

Early Gastric Cancer, Indocyanine Green, Lymph Node Dissection

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Indocyanine Green
Sponsored by
Fujian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  1. Age from 18 to 75 years
  2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
  3. Clinical stage tumor T1 (cT1), N0/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Eighth Edition. Preoperative staging was made by conducting mandatory computed tomography (CT) scans and an optional endoscopic ultrasound
  4. No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations
  5. Tumor located in the lower third of the stomach, expected to receive radical distal gastrectomy
  6. Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
  7. American Society of Anesthesiology score (ASA) class I, II, or III
  8. Written informed consent

Exclusion Criteria:

  1. Women during pregnancy or breast-feeding
  2. Severe mental disorder
  3. History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
  4. History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
  5. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
  6. History of other malignant disease within past five years
  7. History of previous neoadjuvant chemotherapy or radiotherapy
  8. History of unstable angina or myocardial infarction within past six months
  9. History of cerebrovascular accident within past six months
  10. History of continuous systematic administration of corticosteroids within one month
  11. Requirement of simultaneous surgery for other disease
  12. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  13. Forced expiratory volume in 1 second (FEV1)<50% of predicted values
  14. Rejection of laparoscopic resection
  15. Preoperatively confirmed tumors invading the dentate line or duodenum
  16. History of allergy to iodine agents
  17. Tumor located in the upper third of the stomach, expected to receive radical total gastrectomy

Sites / Locations

  • Department of Gastric Surgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: Indocyanine Green Tracer

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

True positive rate
The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes
False positive rate
The number of negative lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes
True negative rate
The number of negative lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes
Total number of retrieved lymph nodes
Total number of retrieved lymph nodes
Lymph node noncompliance rate
Lymph node noncompliance was defined as the absence of lymph nodes that should have been excised from more than 1 lymph node station. Major lymph node noncompliance was defined as more than 2 intended lymph node stations that were not removed.
Number of Metastasis Lymph Nodes
Number of Metastasis Lymph Nodes
Metastasis rate of lymph node
Metastasis rate of lymph node
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 overall survival rate
3-year overall survival rate
3-year disease free survival rate
3-year disease free survival rate
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.
Intraoperative morbidity rates
The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
Time to first ambulation
Time to first ambulation in hours is used to assess the postoperative recovery course.
Time to first flatus
Time to first flatus in days is used to assess the postoperative recovery course.
Time to first liquid diet
Time to first liquid diet in days is used to assess the postoperative recovery course.
Time to first soft diet
Time to first soft diet in days is used to assess the postoperative recovery course.
Duration of postoperative hospital stay
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
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 variation of C-reactive protein

Full Information

First Posted
July 13, 2021
Last Updated
July 13, 2021
Sponsor
Fujian Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04973475
Brief Title
Indocyanine Green Tracer Using in Laparoscopic Distal Gastrectomy for Early Gastric Cancer
Official Title
Prospective Clinical Trials on Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Distal Gastrectomy With Lymph Node Dissection for Early Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2021 (Anticipated)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2026 (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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aims to explore the value of indocyanine green (ICG) in laparoscopic distal gastrectomy with lymph node dissection for early gastric cancer.The patients with early gastric adenocarcinoma (cT1, N-/+, M0) will be studied.
Detailed Description
After being informed about the study and potential risks, all patients giving written informed consent will receiving injection of indocyanine greenat 8 points around the primary tumor with gastroscope 1 day before surgery. During the operation, laparoscopic gastrectomy and perigastric lymph node dissection were performed under ICG imaging equipment. After the surgical specimens were isolated, under the fluorescent illumination of the ICG imaging equipment, the lymph nodes that showed fluorescence and the lymph nodes that did not show fluorescence were collected from each LN station.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Indocyanine Green Tracer
Arm Type
Experimental
Arm Description
Indocyanine Green Tracer will be used in laparoscopic distal gastrectomy with lymph node dissection for gastric adenocarcinoma.
Intervention Type
Drug
Intervention Name(s)
Indocyanine Green
Other Intervention Name(s)
ICG
Intervention Description
Laparoscopic distal gastrectomy with lymph node dissection for early gastric cancer using Indocyanine Green Tracer
Primary Outcome Measure Information:
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
Time Frame
One month after surgery
Secondary Outcome Measure Information:
Title
True positive rate
Description
The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes
Time Frame
One month after surgery
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
Time Frame
One month after surgery
Title
True 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
Time Frame
One month after surgery
Title
Total number of retrieved lymph nodes
Description
Total number of retrieved lymph nodes
Time Frame
One month after surgery
Title
Lymph node noncompliance rate
Description
Lymph node noncompliance was defined as the absence of lymph nodes that should have been excised from more than 1 lymph node station. Major lymph node noncompliance was defined as more than 2 intended lymph node stations that were not removed.
Time Frame
One month after surgery
Title
Number of Metastasis Lymph Nodes
Description
Number of Metastasis Lymph Nodes
Time Frame
One month after surgery
Title
Metastasis rate of lymph node
Description
Metastasis rate of lymph node
Time Frame
One month after surgery
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
One month after surgery
Title
3-year overall survival rate
Description
3-year overall survival rate
Time Frame
36 months
Title
3-year disease free survival rate
Description
3-year disease free survival rate
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
Intraoperative morbidity rates
Description
The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
Time Frame
1 day
Title
Time to first ambulation
Description
Time to first ambulation in hours is used to assess the postoperative recovery course.
Time Frame
30 days
Title
Time to first flatus
Description
Time to first flatus in days is used to assess the postoperative recovery course.
Time Frame
30 days
Title
Time to first liquid diet
Description
Time to first liquid diet in days is used to assess the postoperative recovery course.
Time Frame
30 days
Title
Time to first soft diet
Description
Time to first soft diet in days is used to assess the postoperative recovery course.
Time Frame
30 days
Title
Duration of postoperative hospital stay
Description
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
Time Frame
30 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 variation of C-reactive protein
Time Frame
Preoperative 3 days and postoperative 1, 3, and 5 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 Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy Clinical stage tumor T1 (cT1), N0/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Eighth Edition. Preoperative staging was made by conducting mandatory computed tomography (CT) scans and an optional endoscopic ultrasound No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations Tumor located in the lower third of the stomach, expected to receive radical distal gastrectomy 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 Forced expiratory volume in 1 second (FEV1)<50% of predicted values Rejection of laparoscopic resection Preoperatively confirmed tumors invading the dentate line or duodenum History of allergy to iodine agents Tumor located in the upper third of the stomach, expected to receive radical total gastrectomy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chang-Ming Huang, MD
Phone
+86-13805069676
Email
hcmlr2002@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zu-Kai Wang, MD
Phone
+86-15659036263
Email
413966027@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang-Ming Huang, MD
Organizational Affiliation
Fujian Medical University Union Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Gastric Surgery
City
Fuzhou
State/Province
Fujian
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang-Ming Huang, Huang
Phone
Huang
Email
hcmlr2002@163.com

12. IPD Sharing Statement

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Indocyanine Green Tracer Using in Laparoscopic Distal Gastrectomy for Early Gastric Cancer

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