Delayed Gastric Emptying, Gastric Emptying Time, Postoperative Nausea and Vomiting
Conditions
Keywords
Delayed Gastric Emptying, Pylorus-Preserving Pancreatoduodenectomy, PPPD, Pyloric Balloon Dilatation, Early Postoperative Vomiting, Pylorospasm
Brief summary
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.
Detailed description
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. The primary outcome measure is the incidence of DGE (ISGPS Grade B or C) and early postoperative vomiting within the first seven days after surgery. Secondary outcomes include the time to first flatus, resumption of oral diet, duration of nasogastric tube placement, and overall length of hospital stay.
Interventions
PROCEDUREIntraoperative Pyloric Balloon 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.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Delayed Gastric Emptying (DGE) | 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. |
Outcome results
None listed