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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICG | Experimental | Laparoscopic gastrectomy Group with the use of near-infrared imaging (ICG group) |
|
| Non-ICG | Active Comparator | Laparoscopic gastrectomy Group without the use of near-infrared imaging (Non-ICG group) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine Green Tracer | Drug | Laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer using Indocyanine Green Tracer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Retrieved Lymph Nodes | Total Number of Retrieved Lymph Nodes | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Lymph node noncompliance rate | Lymph node noncompliance rate | 30 days |
| 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 |
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Inclusion Criteria:
(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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hualong Zheng | Contact | +8618359190587 | 291167038@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Recruiting | Fuzhou | Fujian | 350000 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 30 days |
| 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 |
| 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 |
| 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 |
| Number of Metastasis Lymph Nodes | Number of Metastasis Lymph Nodes | 30 days |
| Metastasis rate of lymph node | Metastasis rate of lymph node | 30 days |
| Postoperative morbidity rate | Postoperative morbidity rate | 30 days |
| Postoperative mortality rate | Postoperative mortality rate | 30 days |
| 3-year overall survival rate | 3-year overall survival rate | 3 years |
| 3-year disease-free survival rate | 3-year disease-free survival rate | 3 years |
| 3-year recurrence pattern | 3-year recurrence pattern | 3 years |
| Postoperative recovery course | Time to first ambulation, flatus, liquid diet and soft diet, and postoperative hospital stay | 30 days |
| Intraoperative situation | Operation time, intraoperative blood loss, and intraoperative morbidity rate | 30 days |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |