The Effect of Chemoradiotherapy on Gastric Perfusion in Patients With Gastric Cancer.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Difference in gastric perfusion
研究概览
简要总结
A study from our group (Osterkamp et al. in preparation) used ICG to evaluate intraoperative changes in gastric perfusion when reducing the circulating blood volume by blood withdrawal in pigs. We saw a significant reduction in gastric perfusion with decreased blood volume, and this reduction of gastric perfusion was detectable with ICG. As data from a previous trial (PRESET phase 2 Protocol nr: H-15014904) has shown that chemotherapy decreases the circulating red blood cell volume in patients with gastroesophageal cancer, we wish to evaluate if standard care neoadjuvant chemotherapy also influences gastric perfusion. Gastric perfusion will be assessed during a screening laparoscopy (before chemotherapy) and then compared with a second assessment during gastric resection (after chemotherapy). The gastric perfusion will be measured using fluorescence-guided surgery with Indocyanine Green.
Participants will be offered the opportunity to have their blood volume measured during the trial. This is not required in order to take part in the fluorescence angiography part of the study.
详细描述
Screening Laparoscopy:
As part of the standard care for gastric cancer, all patients undergo a screening laparoscopy before entering neoadjuvant chemotherapy. The procedure is performed to detect overt metastases not detected on the CT/PET-CT scans. First, the patient is placed under a standardized general anesthesia, and the laparoscopic set-up is completed. After anesthesia a peripheral arterial catheter will be placed in order acquire reading of cardia output and stroke volume. The patient will then be fluid optimized using a standardized stroke volume (SV) optimization algorithm. The abdomen is inspected visually for signs of metastatic disease. The small bowel is then manipulated, allowing for visualization of the stomach. A bolus of ICG (0.2 mg/kg body weight) will be injected intravenously and flushed with 5 mL of saline. Gastric perfusion will subsequently be assessed along specific regions of interest (ROI) with q-ICG to obtain baseline perfusion values.
As a substudy, 10 patients will have two measurements with ICG during the screening laparoscopy, one befor eand one after fluid optimization. These patients will receive an ICG dose of 0.1 mg/kg body weight per measurement, totalling 0.2 mg/kg after the two measurements.
Resection of gastric cancer:
The patient is placed under general anesthesia and after the stomach is visualized through surgical incision, a bolus of ICG (0.2 mg/kg body weight) will be injected intravenously and flushed with 5 mL of saline. The ROIs (the same ROIs as described in 3.7.1) will then be assessed with q-ICG. The anesthetic protocol will up to this point match that of the setting during the screening laparoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (above 18 years) scheduled for planned open or robot-assisted resection of gastric cancer.
排除标准
- •Allergy towards; iodine, indocyanine green or shellfish
- •Severe liver insufficiency
- •Thyrotoxicosis
- •Nephropathy requiring dialysis
- •Pregnancy or lactation
- •Legally incompetent for any reason
- •Withdrawal of inclusion consent
- •Disseminated disease or other that contraindicates curative surgery
研究组 & 干预措施
ICG patient
All patients included in the study will be injected with ICG (0.2 mg/kg bodyweight) to assess gastric perfusion.
干预措施: Indocyanine green (Drug)
结局指标
主要结局
Difference in gastric perfusion
时间窗: 2 years
The primary endpoint is the difference in gastric perfusion (obtained with q-ICG, using the slope of the fluorescence curve (as described by Nerup et al)) before and after neoadjuvant chemotherapy. A comparison of the gastric perfusion before and after chemotherapy will be performed using Friedman's test or a repeated measures ANOVA / linear mixed-effects depending on a non- or parametric nature of the data. A P-value \< 0.05 will be considered significant. Statistic evaluation will be performed using IBM SPSS Statistics © (v 22.0 SPSS Inc. Chicago, IL, USA).
次要结局
- Short term outcome(30 days after surgery)
研究者
JENS OSTERKAMP
MD, PhD-student, Principal Investigator
Rigshospitalet, Denmark
