Intraoperative Pyloric Balloon Dilatation to Reduce Delayed Gastric Emptying After PPPD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intraoperative Pyloric Balloon Dilatation.
- Who it may be relevant to
- Registry conditions: Delayed Gastric Emptying, Postoperative Nausea and Vomiting, Gastric Emptying Time. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intraoperative Pyloric Balloon Dilatation to Decrease Post PPPD Delayed Gastric Emptying. Does It Help? RCT Study
Overview
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
- Procedure Intraoperative 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.
Primary outcome measures
- Incidence of Delayed Gastric Emptying (DGE) [Time frame: Up to 7 days postoperatively]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07451392 · Intraoperative Pyloric Balloon