A Modified "Arch-bridge-type" Esophagogastric Reconstruction Method After Laparoscopic Proximal Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Postoperative long-term quality of life (QoL)
研究概览
简要总结
The double-flap technique (DFT) is an effective digestive tract reconstruction method after proximal gastrectomy (PG) to reduce the incidence of postoperative reflux esophagitis. But its clinical application is restricted due to the technical complexity. Our surgical team devise a modified esophagogastric reconstructive method which we term the "arch-bridge-type" reconstruction based on the principle of DFT. The aim of this single-arm prospective study is to assess the safety and feasibility of the "arch-bridge-type" reconstruction after PG.
详细描述
- The lymphadenectomy is performed according to the Japanese Gastric Cancer Treatment Guidelines.
- Transection of the esophagus is performed using a linear stapler 2cm away from the proximal end of the tumor.
- Creating the seromuscular flap ("arch-bridge"):
(1) The stomach is resected by a linear stapling device. (2) A "匚" shaped seromuscularflap (3.0cm×4.0cm) is created utilizing electrocautery extracorporeally by dissecting submocosal and muscular layer of the anterior wall of the remnant stomach.
(3) The opening of the flap is interrupted sutured by 4-0 absorbable suture, then the "arch-bridge" is created.
4.The remnant stomach is then inserted into the abdominal cavity, and pneumoperitoneum is re-established to perform the intracorporeal anastomosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically proven proximal gastric cancer or adenocarcinoma of esophagogastric junction
- •diameter of the tumor less than 4cm
- •ECOG performance status score ≤2
- •no distant metastasis
- •informed consent is signed
排除标准
- •metastatic gastric cancer or metastatic adenocarcinoma of esophagogastric junction
- •remnant gastric cancer
- •patient requires emergency surgery
结局指标
主要结局
Postoperative long-term quality of life (QoL)
时间窗: 1 year after surgery
The QoL is evaluated by postgastrectomy symptom assessment scale (PGSAS-45). Postoperative reflux, abdominal pain, postprandial discomfort, dyspepsia, diarrhea, constipation, dumping syndrome, weight change, food intake per meal, frequency of additional meals, digestive ability, daily work ability, and satisfaction with quality of life will be evaluated in PGSAS-45.
Surgical safety
时间窗: From surgery day to 30 days after surgery
The incidence of postoperative complications which were graded using the Clavien-Dindo classification system. The postoperative complications include anastomotic leackage, anastomotic stenosis, abdominal bleeding, gastric emptying disorder, pneumonia complications, etc.
次要结局
- Postoperative body weight status(1 year after surgery)
- Postoperative hemoglobin(1 year after surgery)
- Postoperative reflux esophagitis(1 year after surgery)
- Refinement of surgery(From surgery day to 30 days after surgery)
研究者
Ziyu Li, MD
Dr. Prof.
Peking University