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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05618821
• Other study ID #: FUGES-027
• Status: Recruiting
• Phase: Phase 2
• Start date: June 3, 2022
• Est. completion date: April 1, 2028

Study information

• Verified date: November 2022
• Source: Fujian Medical University
• Contact: Hualong Zheng
• Phone: +8618359190587
• Email: 291167038[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: April 1, 2028
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age from 18 to 75 years

2. 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:

1. Women during pregnancy or breast-feeding

2. Severe mental disorder

3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy and gastrectomy)

4. History of previous gastric surgery (including ESD/EMR for gastric cancer)

5. Rejection of laparoscopic resection

6. History of allergy to iodine agents

7. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging

8. History of other malignant disease within past five years

9. History of previous neoadjuvant chemotherapy or radiotherapy

10. History of unstable angina or myocardial infarction within the past six months

11. History of unstable angina or myocardial infarction within past six months

12. History of continuous systematic administration of corticosteroids within one month

13. Requirement of simultaneous surgery for another disease

14. Emergency surgery due to complications (bleeding, obstruction or perforation) caused by gastric cancer

15. FEV1<50% of the predicted values

16. Linitis plastica, Widespread

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Indocyanine Green Tracer
Laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer using Indocyanine Green Tracer

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Number of Retrieved Lymph Nodes	Total Number of Retrieved Lymph Nodes	30 days
Secondary	Lymph node noncompliance rate	Lymph node noncompliance rate	30 days
Secondary	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	30 days
Secondary	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)	30 days
Secondary	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)	30 days
Secondary	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)	30 days
Secondary	Number of Metastasis Lymph Nodes	Number of Metastasis Lymph Nodes	30 days
Secondary	Metastasis rate of lymph node	Metastasis rate of lymph node	30 days
Secondary	Postoperative morbidity rate	Postoperative morbidity rate	30 days
Secondary	Postoperative mortality rate	Postoperative mortality rate	30 days
Secondary	3-year overall survival rate	3-year overall survival rate	3 years
Secondary	3-year disease-free survival rate	3-year disease-free survival rate	3 years
Secondary	3-year recurrence pattern	3-year recurrence pattern	3 years
Secondary	Postoperative recovery course	Time to first ambulation, flatus, liquid diet and soft diet, and postoperative hospital stay	30 days
Secondary	Intraoperative situation	Operation time, intraoperative blood loss, and intraoperative morbidity rate	30 days