Gastric Cancer, Surgery
Conditions
Keywords
Gastric Cancer, Laparoscopic Gastrectomy, Indocyanine Green Tracer
Brief summary
Taking patients with locally advanced gastric adenocarcinoma (cT2-4a, N-/+, M0) as the research subjects, to evaluate whether the clinical efficacy of laparoscopic beyond D2 regional lymph node dissection for gastric cancer with indocyanine green tracer is better or not.
Interventions
PROCEDUREbeyond D2 regional lymph node dissection
dissect the lymph nodes outside the extent of D2 LN region.
Sponsors
Fujian Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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 cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual, 8th Edition No distant metastasis, no direct invasion of pancreas, spleen or other adjacent organs in the preoperative examinations Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale ASA (American Society of Anesthesiology) class I to III Written informed consent
Exclusion criteria
Women during pregnancy or breast-feeding Severe mental disorder History of previous upper abdominal surgery (except for laparoscopic cholecystectomy) History of previous gastric surgery (including ESD/EMR for gastric cancer) Enlarged or bulky regional lymph node (diameter over 3cm) supported by preoperative imaging including enlarged or bulky lymph nodes in D3 region. Other malignant disease within the past 5 years 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 for simultaneous surgery for other disease Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer FEV1 (forced expiratory volume in one second)\<50% of predicted values Diffuse invasive gastric cancer Tumors preoperatively confirmed to involve the squamocolumnar junction or duodenum History of an iodine allergy Patients who declined laparoscopic surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year disease free survival rate | 3 years | Disease-free survival is calculated from the day of surgery to the day of recurrence or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Noncompliance rate of lymph node dissection | 30 days | The LN dissection rate was determined by the number of patients in whom a LN station was harvested divided by the total number of patients who required retrieval at the corresponding LN station. Within the scope of D2 dissection, LN noncompliance was defined as the absence of LNs that should have been resected from \> 1 LN station. |
| Relationship between fluorescent lymph nodes in group A and total number of lymph nodes in group A | 30 days | Relationship between the number of fluorescent lymph nodes in group A and total number of lymph nodes in group A |
| Relationship between fluorescent lymph nodes in Group A and positive lymph nodes in Group A (positive rate) | 30 days | The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in Group A (True positive rate). |
| Relationship between fluorescent lymph nodes in Group A and negative lymph nodes in Group A (false positive rate) | 30 days | The number of negative lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in Group A (false positive rate). |
| Relationship between non-fluorescent lymph nodes in Group A and negative lymph nodes in group A (negative rate) | 30 days | The number of negative lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in group A (True negative rate). |
| Relationship between nonfluorescent lymph nodes in Group A and positive lymph nodes in Group A (false negative rate) | 30 days | The number of positive lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in Group A (false negative rate). |
| Relationship between fluorescent lymph nodes in group B and total number of lymph nodes in group B | 30 days | Relationship between the number of fluorescent lymph nodes in group B and total number of lymph nodes in group B |
| Relationship between fluorescent lymph nodes in Group B and positive lymph nodes in Group B (positive rate) | 30 days | The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in Group B (True positive rate). |
| Relationship between fluorescent lymph nodes in Group B and negative lymph nodes in Group B (false positive rate) | 30 days | The number of negative lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in Group A (false positive rate). |
| Relationship between non-fluorescent lymph nodes in Group B and negative lymph nodes in group B (negative rate) | 30 days | The number of negative lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in group B (True negative rate). |
| Total number of retrieved lymph nodes | 30 days | Total number of retrieved lymph nodes |
| Number of metastatic lymph nodes | 30 days | Number of metastatic lymph nodes |
| Metastasis rate of lymph nodes | 30 days | Metastasis rate of lymph nodes |
| Postoperative complications | 30 days | Postoperative complications were evaluated within 30 days following surgery. These postoperative complications include gastrointestinal-related complications, incision-related complications, respiratory complications, cardiovascular and cerebrovascular complications, urinary system complications, infection complications, embolism complications, and other complications. The grading of postoperative complications adopts the Clavien-Dindo classification. |
| Mortality rates | 30 days | Patient died during hospitalization. |
| 3-year overall survival rate | 3 years | 3-year overall survival rate |
| 3-year recurrence pattern | 3 years | 3-year recurrence pattern |
| Postoperative recovery course | 30 days | Time to first flatus after surgery, time to first ambulation after surgery, time to first liquid diet after surgery, time to first semi-liquid diet after surgery, length of hospital stay after surgery. |
| The incidence of intraoperative complications | 30 days | Intraoperative complications were defined as bleeding due to named vessel injury, injury to visceral organs, mechanical factor-related problems, cardiopulmonary dysfunction due to hypercapnia, and other complications |
| Inflammatory and immune response | 7 days | the values of hemoglobin, prealbumin, albumin, C-reactive protein, and white blood cell count from peripheral blood before the operation and on postoperative day 1, 3, 5 are recorded. |
| Relationship between nonfluorescent lymph nodes in Group B and positive lymph nodes in Group B (false negative rate) | 30 days | The number of positive lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in Group B (false negative rate). |
Countries
China
Contacts
Primary ContactMi Lin, phD
Backup ContactHua-Long Zheng, phD
Outcome results
None listed