Impact of Side to Side Gastrojejunostomy on the Rate of Delayed Gastric Emptying After Pancreaticoduodenectomy: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 166
- 试验地点
- 4
- 主要终点
- Post-operative delayed gastric emptying
研究概览
简要总结
Prospective bi-centric randomized open-label study comparing side to side and end to side gastrojejunostomy in pancreaticoduodenectomy
详细描述
Delayed gastric emptying is one of the main complications occurring after pancreatodudodenectomy, the incidence of which is estimated between 10 and 40% in the literature. Its occurrence leads to an alteration in post-operative quality of life (maintenance or resting of the nasogastric tube) and is the primary reason an increase in the length of hospital stay and therefore the cost of treatment. In addition, it predisposes to the risk of inhalation pneumopathy, which increases the risk of post-operative death. Various technical surgical points have been suggested by retrospective studies to reduce its incidence (pyloric preservation, respect for the left gastric vein, ante-colic positioning of the Child's handle, making a Y-shaped handle) but without ever being validated in randomized prospective studies.
Recently three retrospective studies have highlighted the interest of performing a side to side l rather than an end to side gastro-jejunal anastomosis to reduce the rate of post-operative delayed gastric emptying.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •patient over 18 years old
- •to benefit from a cephalic duodenopancreatectomy whatever the indication (benign and malignant tumor)
- •affiliated with a health insurance system
- •having received oral and written information about the protocol and having signed a free and informed written consent.
排除标准
- •associated organ resection except for portal vein or hepatic artery resection.
- •history of gastric or esophageal resection
- •person subject to legal protection (safeguard justice, trusteeship and guardianship) and persons deprived of liberty
- •pregnant or breastfeeding women
- •patient participating in another clinical trial that may interfere with the protocol.
结局指标
主要结局
Post-operative delayed gastric emptying
时间窗: Day 90
Occurrence of post-operative delayed gastric emptying (classified to the International Study Group for Pancreatic Surgery (ISGPS))
次要结局
- Biliary fistula(Up to day 90)
- Gastrointestinal Quality of Life Index (GIQLI)(Up to day 90)
- Mortality rate(Day 90)
- Haemorrhage(Up to day 90)
- Pancreatic fistula(Up to day 90)
- First gas(Up to five days after surgery)
- Pre-operative to 3-month post-operative weight ratio(Up to day 90)
- Occurrence of Clavien-Dindo complications(Up to day 90)
- Food intake (liquid and solid)(Up to five days after surgery)
- General Quality of Life Score for Digestive Pathologies(Up to day 90)
- Albumin and prealbumin levels(Up to day 90)
- Time to functional recovery (days) after surgery(Day 90)