Intraoperative Pyloric Balloon Dilatation to Decrease Post PPPD Delayed Gastric Emptying. Does It Help? RCT Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- Incidence of Delayed Gastric Emptying (DGE)
研究概览
简要总结
Pylorus-preserving pancreatoduodenectomy (PPPD) is a standard surgical treatment for tumors of the pancreatic head and surrounding areas. However, it is frequently associated with delayed gastric emptying (DGE), a complication that can lead to nausea, vomiting, and prolonged hospital stays. This study is a randomized controlled trial designed to evaluate if a simple intraoperative maneuver (pneumatic balloon dilatation of the pylorus) can reduce the incidence of early postoperative vomiting and DGE.
Participants will be randomly assigned to either the intervention group, receiving pyloric dilatation during surgery, or the control group, receiving standard surgery without dilatation. Researchers will monitor postoperative symptoms, gastric emptying function, and overall recovery to determine if this maneuver effectively improves patient outcomes.
详细描述
Pylorus-preserving pancreatoduodenectomy (PPPD) is a standard surgical approach for treating tumors of the pancreatic head, duodenum, and distal cholangiocarcinomas. While it offers favorable functional and nutritional outcomes compared to the classic Whipple procedure, it is frequently complicated by delayed gastric emptying (DGE), with reported incidence rates as high as 25-50%. DGE leads to symptoms such as nausea, vomiting, and early satiety, significantly increasing morbidity and prolonging hospital stays.
The pathophysiology of DGE is multifactorial, but pylorospasm, which results from intraoperative denervation, local ischemia, and postoperative edema, is believed to be a major contributor. Intraoperative maneuvers aimed at reducing pyloric tone, such as mechanical dilatation, have been proposed to facilitate gastric outflow without sacrificing the physiological benefits of preserving the pylorus.
This prospective, randomized controlled trial is designed to evaluate whether intraoperative pneumatic balloon dilatation of the pylorus can reduce the incidence and severity of early postoperative DGE. The study will be conducted at Assiut University Hospital and Al-Rajhi Hospital. Seventy adult patients scheduled for elective PPPD will be randomized into two groups:
Intervention Group: Following the resection and prior to reconstruction, a sterile, calibrated pneumatic balloon dilator will be positioned across the pylorus and inflated to 18-20mm for 1-2 minutes to achieve mechanical stretching.
Control Group: Patients will undergo the standard PPPD procedure without any additional pyloric manipulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Adult patients (≥18 years) scheduled for elective PPPD due to tumors of the pancreatic head, distal bile duct, or ampulla of Vater.
- •Patients with no prior history of gastric surgery or severe gastroparesis.
- •Patients with no contraindications to balloon dilatation or intraoperative endoscopic procedures
排除标准
- •Patients with prior gastric surgery, pyloric stenosis, or history of severe gastroparesis.
- •Patients with severe comorbidities that may preclude safe surgery (ASA class IV or higher).
- •Patients who require emergency surgery or have unresectable disease.
- •Patients with active gastrointestinal bleeding or severe malnutrition
研究组 & 干预措施
Pyloric Dilatation
A sterile, calibrated pneumatic balloon dilator will be positioned across the pylorus under direct vision. The balloon will be inflated to a predetermined diameter (typically 18-20mm) for 1-2 minutes, repeated once if necessary, to achieve gentle mechanical stretching of the pylorus. The procedure will be performed after completion of the pancreatoduodenectomy and before gastrointestinal reconstruction.
干预措施: Intraoperative Pyloric Balloon Dilatation (Procedure)
No Pyloric Dilatation
No additional intervention will be performed at the pylorus. The standard PPPD procedure will be completed without balloon dilatation or any other pyloric manipulation.
结局指标
主要结局
Incidence of Delayed Gastric Emptying (DGE)
时间窗: Up to 7 days postoperatively
The occurrence of delayed gastric emptying will be evaluated and defined according to the International Study Group of Pancreatic Surgery (ISGPS) criteria (specifically grades B or C), which are based on the severity and duration of nasogastric tube use and the patient's inability to tolerate oral intake.
次要结局
未报告次要终点
研究者
Taha Hussein Taha Hussein Khalil
Resident at General Surgery Department, Assiut University
Assiut University