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

Phase 2

Not yet recruiting

• Conditions: Lymph Node Dissection; Early Gastric Cancer; Indocyanine Green
• Interventions: Drug: Indocyanine Green

• Registration Number: NCT04973475
• Lead Sponsor: Fujian Medical University

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.

Study Timeline

• Status Verified: 2021-07
• Study Start: 2021-07
• Study First Submitted: 2021-07-13
• Study First Submitted QC: 2021-07-13
• Last Update Submitted: 2021-07-13
• Study First Posted: 2021-07-22
• Last Update Posted: 2021-07-22
• Primary Completion: 2023-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: Indocyanine Green Tracer	Indocyanine Green	Indocyanine Green Tracer will be used in laparoscopic distal gastrectomy with lymph node dissection for gastric adenocarcinoma.

Primary Outcome Measures

Name	Time	Method
False negative rate	One month after surgery	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

Name	Time	Method
False positive rate	One month after surgery	The number of negative lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes
Number of Metastasis Lymph Nodes	One month after surgery	Number of Metastasis Lymph Nodes
The variation of white blood cell count	Preoperative 3 days and postoperative 1, 3, and 5 days	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.
3-year recurrence pattern	36 months	Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.
Time to first flatus	30 days	Time to first flatus in days is used to assess the postoperative recovery course.
Total number of retrieved lymph nodes	One month after surgery	Total number of retrieved lymph nodes
Lymph node noncompliance rate	One month after surgery	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.
3-year overall survival rate	36 months	3-year overall survival rate
3-year disease free survival rate	36 months	3-year disease free survival rate
The variation of hemoglobin	Preoperative 3 days and postoperative 1, 3, and 5 days	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	Preoperative 3 days and postoperative 1, 3, and 5 days	The variation of C-reactive protein
True positive rate	One month after surgery	The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes
True negative rate	One month after surgery	The number of negative lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes
Metastasis rate of lymph node	One month after surgery	Metastasis rate of lymph node
Morbidity and mortality rates	One month after surgery	This is for the early postoperative complication and mortality, which defined as the event observed within 30 days after surgery.
Intraoperative morbidity rates	1 day	The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
Time to first ambulation	30 days	Time to first ambulation in hours is used to assess the postoperative recovery course.
Time to first liquid diet	30 days	Time to first liquid diet in days is used to assess the postoperative recovery course.
Time to first soft diet	30 days	Time to first soft diet in days is used to assess the postoperative recovery course.
Duration of postoperative hospital stay	30 days	Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.

Trial Locations

Locations (1)

Department of Gastric Surgery; 🇨🇳 Fuzhou, Fujian, China