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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
Endoscopic injection
Endoscopic injection
Fourth Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Total Number of Retrieved Lymph Nodes
Compare total number of retrieved lymph nodes in both group.
Time frame: 10 days
The rate of black-stained/fluorescence
The number of black-stained/fluorescent lymph node in experimental group is divided by the total number of lymph nodes in active experimental group
Time frame: 10 days
Positive rate
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
Time frame: 10 days
False positive rate
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
Time frame: 10 days
Negative rate
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
Time frame: 10 days
False negative rate
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
Time frame: 10 days
Number of Metastasis Lymph Nodes
Compare number of positive lymph nodes in both group.
Time frame: 10 days
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Morbidity and mortality rates
This is for the early postoperative complication and mortality, which defined as the event observed within 30 days after surgery.
Time frame: 30 days
3-year disease free survival rate
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.
Time frame: 36 months
3-year recurrence pattern
Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.
Time frame: 36 months
Intraoperative blood loss
Intraoperative blood loss
Time frame: 1 day
Postoperative lymph node anatomy duration
Postoperative lymph node anatomy duration
Time frame: 1 day