Comparison of Subtotal Stomach and Narrow Gastric Tube for Reconstruction After Esophagectomy for Gastric Cancer: a Prospective Randomized Control Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Early complications (30-day complications): rate of anastomotic stricture
研究概览
简要总结
Currently, both the subtotal stomach and narrow gastric tube approaches are widely used for esophagogastric anastomosis after esophagectomy. Some stud- ies have concluded that the subtotal gastric conduit is superior to the wide gastric-tube approach, as it provides better protection of the submucosal vessels and can slightly increase gastric capacity.
Furthermore, blood perfusion significantly decreases after tubular gastric surgery.
详细描述
Stomach is the most common esophageal subtitute after a esophagectomy procedure, because it has a abundant blood supply and the need for only one anastomosis. However, cervical esophago-gastro anastomosis still has a high risk of complications, especially anastomosis leakage (11.9 - 25 % ).
There are three types of gastric subtitute: whole stomach, subtotal stomach and narrow gastric tube. While whole stomach and subtotal stomach has an advantage in the submucosal vascular network, a narrow tube is excellent elasticity and the ease with which it can be pulled up into the neck without tension, that could affect leakage rate.
On the other hand, after esophagectomy, nutrition status and quality of life (QoL) had decreased due to effect of adjuvant therapy, lower quantity of food intake, gastro-esophageal reflux and other postoperative syndromes. Several studies had shown the affect of the width of gastric tube to the postoperative nutrition and QoL, however, the results were not homogenous. This study aims to compared two types of gastric subtitute after esophagectomy: subtotal stomach and narrow gastric tube
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologic finding by esophageal endoscopy: confirmed esophageal cancer.
- •Indication for esophagectomy
- •Age: 18 - 80 year old
- •Tumor located at the middle or lower third of the esophagus
- •ASA score: ≤ 3
- •Informed consent patients (explanation about our clinical trials is provided to the patients or patrons, if patient is not available)
排除标准
- •Concurrent cancer or patient who was treated due to other cancer before the patient was diagnosed esophageal cancer
- •Pregnant patient
- •Using colon or intesinal conduit
研究组 & 干预措施
Subtotal stomach
The vessels at the anastomosis of right and left gastric arteries were separated, then the proximal haft of lesser curvature and cardia was resected using linear staplers.
干预措施: Narrow gastric tube (Procedure)
Narrow gastric tube
At the lesser curvature, the resection began at the point that was 5-cm from the pyloric, toward to the greater curvature, then the stomach was divided along 3 cm from the greater curvature using linear stapler.
干预措施: Narrow gastric tube (Procedure)
结局指标
主要结局
Early complications (30-day complications): rate of anastomotic stricture
时间窗: 30 days after surgery
Comparison of the rate of anastomotic stricture. All complications will be classified according to the Clavien-Dindo classification.
Early complications (30-day complications): rate of bleeding
时间窗: 30 days after surgery
Comparison of the rate of bleeding. All complications will be classified according to the Clavien-Dindo classification.
Early complications (30-day complications): rate of pneumonia
时间窗: 30 days after surgery
Comparison of the rate of pneumonia. All complications will be classified according to the Clavien-Dindo classification.
Early complications (30-day complications): rate of mortality.
时间窗: 30 days after surgery
Comparison of the rate of anastomotic leakage. All complications will be classified according to the Clavien-Dindo classification.
Early complications (30-day complications): rate of reoperation.
时间窗: 30 days after surgery
Comparison of the rate of reoperation. All complications will be classified according to the Clavien-Dindo classification.
Early outcomes (30-day post operative): length of hospital stay.
时间窗: 30 days after surgery
Comparison of the length of hospital stay.
Early outcomes (30-day post operative): day of oral intake.
时间窗: 30 days after surgery
Comparison of the day of oral intake.
Early complications (30-day complications): rate of anastomotic leakage
时间窗: 30 days after surgery
Comparison of the rate of anastomotic leakage. All complications will be classified according to the Clavien-Dindo classification.
次要结局
- Postoperative nutritional status: body weight(6, 12 months and 1 year after surgery)
- Postoperative nutritional status: serum total protein(6, 12 months and 1 year after surgery)
- Postoperative nutritional status: albumin level(6, 12 months and 1 year after surgery)
- Postoperative nutritional status: hemoglobin(6, 12 months and 1 year after surgery)
- Patients' health-related quality of life(6, 12 months and 1 year after)
- Late complications: anastomotic stricture(6, 12 months and 1 year after)
- Late complications: anastomotic ulcer(6, 12 months and 1 year after)
- Others late complications(6, 12 months and 1 year after)
- Reflux esophagitis(6, 12 months and 1 year after surgery)
- Residue Gastritis Bile(6, 12 months and 1 year after)
- Oncological outcomes: overall survival rate(6, 12 months and 1 year after)
- Oncological outcomes: rate of death due to the cancer(6, 12 months and 1 year after)
- Oncological outcomes: recurrence, metastasis(6, 12 months and 1 year after)