Gastric Cancer
Conditions
Brief summary
The purpose of this study is to assess the efficacy and safety of carbon nanoparticle suspension injection and indocyanine green tracer-guided lymph node dissection during gastrectomy in patients with gastric cancer
Detailed description
Da Vinci robot surgery XI system has fluorescence imaging function, which can realize indocyanine green lymph node tracking navigation technology in the operation. At the same time, the lymph node tracking effect of nano carbon suspension injection is not affected by equipment. The flexible mechanical arm of Da Vinci robot combined with the application of lymph node tracing technology makes the lymph node dissection of gastric cancer surgery more thorough, and also reduces the difficulty of surgery. Indocyanine green navigational lymphadenectomy can also be performed by fluorescence laparoscopy. By comparing the two tracer techniques, the lymph node tracer technique which is more suitable for robot or laparoscopic surgery system is selected to provide help and choice for clinical surgeons.
Interventions
Endoscopic injection
DRUGIndocyanine green
Endoscopic injection
Sponsors
Hebei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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 1-4a (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 Eastern Cooperative Oncology Group scale (ECOG) 6. American Society of Anesthesiology score (ASA) class I, II, or 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 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. FEV1\<50% of predicted values 14. Diffuse; widespread; plastica
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Retrieved Lymph Nodes | 10 days | Compare total number of retrieved lymph nodes in both group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive rate | 10 days | The number of positive lymph nodes in black-stained/fluorescent lymph nodes is divided by the number of total black-stained/fluorescent lymph nodes in experimental group |
| False positive rate | 10 days | The number of negative lymph nodes in black-stained/fluorescent lymph nodes is divided by the number of total black-stained/fluorescent lymph nodes in experimental group |
| Negative rate | 10 days | The number of negative lymph nodes in not black-stained/fluorescent lymph nodes is divided by the number of total not black-stained/fluorescent lymph nodes in experimental group |
| False negative rate | 10 days | The number of positive lymph nodes in not black-stained/fluorescent lymph nodes is divided by the number of total not black-stained/fluorescent lymph nodes in experimental group |
| Number of Metastasis Lymph Nodes | 10 days | Compare number of positive lymph nodes in both group. |
| The rate of black-stained/fluorescence | 10 days | The number of black-stained/fluorescent lymph node in experimental group is divided by the total number of lymph nodes in active experimental group |
| 3-year disease free survival rate | 36 months | Disease-free survival is calculated from the day of surgery to the day of recurrence (When the specific date of recurrence of the tumor is unknown, the ending point is the date of death due to tumor causes). In the event that neither death nor recurrence of the tumor are observed, the end point is the final date that a patient is confirmed as relapse-free. |
| 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. |
| Intraoperative blood loss | 1 day | Intraoperative blood loss |
| Postoperative lymph node anatomy duration | 1 day | Postoperative lymph node anatomy duration |
| Morbidity and mortality rates | 30 days | This is for the early postoperative complication and mortality, which defined as the event observed within 30 days after surgery. |
Countries
China
Outcome results
None listed