Pylorus-preserving Pancreaticoduodenectomy Using a Hemi-double-stapling Technique
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Grade of delayed gastric emptying by ISGPS
研究概览
简要总结
Surgical stapler is used in all areas of surgical operation. Surgical stapler has been used in various surgical fields for a long time, so its stability has already been proven. After gastrectomy or colectomy, the hemi-double stapling technique, which is an improved double stapling technique, has been applied as an anastomosis method using a stapler.
In the duodenojejunal anastomosis after PPPD, the hemi-double stapling method can be applied to preserve the pyloric branch of the vagus nerve and the branch of the right gastric artery to ensure sufficient blood supply. Ultimately, it is expected to shorten the anastomosis time as well as reduce the frequency of delayed gastric emptying. In addition, the work of physically expanding the pylorus to insert the circular anastomosis is also thought to reduce gastric emptying delay.
详细描述
(1) Stapling technique
- Make purse-string suture on jejunum at the point of duodenojejunostomy
- Insert Anvil into jejunem
- Make incision of 3-4 centimeters at anterior side of antrum
- Long Kelly forceps are inserted into the stomach to dilate the pylorus
- A 25 mm end-to-end anastomosis (EEA) stapler is inserted into the stomach and passed through the pylorus.
- The needle of EEA stapler is pierced through the lower part of the stapler line where the duodenum has been resected
- The EEA stapler is combined with the anvil and anastomosis is performed
- The incision on the stomach is sutured through a linear stapler
- Reinforcement suture for stapler line
(2) Postoperative management
- Diet build up as same manner of hand-sewn group (3) Postoperative follow-up
- All postoperative complication, delayed gastric emptying, intraperitoneal abscess, postoperative pancreatic fistula, postpancreatectomy hemorrhage, hospital stay, reoperation, readmission and 2-months mortality.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pylorus-preserving pancreaticoduodenectomy
- •ECOG scale 0-1
- •Appropriate organ function as below i.WBC : ≥2500 mm3, ≤14000 mm3 ii.Hemoglobin : ≥9.0 g/dL iii.Platelet : ≥100,000 mm3 iv.Total bilirubin : ≤2.0 mg/dL (except for occlusive jaundice) v.Creatinine : ≤2.0 mg/dL
- •patient who can understand and sign the informed consent
排除标准
- •previous history of gastrectomy
- •ulcerative scar around ampulla of duodenum on endoscopy
- •previous history of upper abdomen surgery (open)
- •Severe ischemic heart disease
- •Severe hepatic failure by liver cirrhosis or hepatitis
- •Severe respiratory failure that requires oxygene inhalation
- •Chronic renal failure that requires hemodialysis
- •Expecting combine resection of other organ
- •Immunosuppressive therapy
- •Accompanying cancer with potential for adverse events
- •Severe psychologic or neurologic disease
- •drug or alcohol addiction
结局指标
主要结局
Grade of delayed gastric emptying by ISGPS
时间窗: At postoperative 21 day
Delayed gastric emptying will be evaluated at postoperative 21 day using International study group of pancreatic surgery (ISGPS) classification. According to ISGPS classification, delayed gastric emptying is divided into three grades from A to C. Grade C means worse than grade A.--\>Unit of Measure: Grade A,B,C
次要结局
- hospital stay(At postoperative 21 day)
研究者
Joon Seong Park
Professor
Gangnam Severance Hospital