Delayed Gastric EmptyingNCT07451392
Intraoperative Pyloric Balloon Dilatation to Reduce Delayed Gastric Emptying After PPPD
A study testing Intraoperative Pyloric Balloon Dilatation in people with Delayed Gastric Emptying and Postoperative Nausea and Vomiting, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delayed Gastric Emptying, Postoperative Nausea and Vomiting, Gastric Emptying Time
- What is being tested?
- Intraoperative Pyloric Balloon Dilatation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Intraoperative Pyloric Balloon Dilatation to Decrease Post PPPD Delayed Gastric Emptying. Does It Help? RCT Study
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.
Read the 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.
- Being tested
- Intraoperative Pyloric Balloon Dilatation
- Keywords
- Delayed Gastric Emptying, Pylorus-Preserving Pancreatoduodenectomy, PPPD, Pyloric Balloon Dilatation, Early Postoperative Vomiting, Pylorospasm
- Medical subject headings
- Gastroparesis, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Pyloric Balloon DilatationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Pyloric Dilatation | Experimental | 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. Receives: Procedure: Intraoperative Pyloric Balloon Dilatation |
| No Pyloric Dilatation | No intervention | No additional intervention will be performed at the pylorus. The standard PPPD procedure will be completed without balloon dilatation or any other pyloric manipulation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Delayed Gastric Emptying (DGE)
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.
Measured: Up to 7 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Gastric EmptyingStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taha Hussein Taha Hussein Khalil, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451392
- Sponsor's protocol ID
- Intraoperative Pyloric Balloon
- Status last verified
- Feb 2026
- First submitted
- 28 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Pyloric Balloon Dilatation to Decrease Post PPPD Delayed Gastric Emptying. Does It Help? RCT Study
- ClinicalTrials.gov ID
- NCT07451392
- Acronym / sponsor ID
- Intraoperative Pyloric Balloon
- Keywords
- Delayed Gastric Emptying, Pylorus-Preserving Pancreatoduodenectomy, PPPD, Pyloric Balloon Dilatation, Early Postoperative Vomiting, Pylorospasm
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pyloric Dilatation | Experimental | Procedure: Intraoperative Pyloric Balloon DilatationA 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. |
| No Pyloric Dilatation | No intervention | –No additional intervention will be performed at the pylorus. The standard PPPD procedure will be completed without balloon dilatation or any other pyloric manipulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative Pyloric Balloon DilatationA 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. | Procedure or surgery | Pyloric Dilatation |
Primary outcome
Incidence of Delayed Gastric Emptying (DGE)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
Related trials for Delayed Gastric Emptying
Recruiting
Gastric Focused Ultrasound Stimulation
Gastroparesis, Delayed Gastric Emptying
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
Not yet recruiting
Stomach-Partitioning Versus Conventional Gastrojejunostomy for Malignant Gastric Outlet Obstruction: A Multicenter Randomized Controlled Trial
Gastric Cancer, Gastric Outlet Obstruction
Recruiting
To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.
Type 1 Diabetes, Gastroparesis Due to Diabetes Mellitus Type I
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative Pyloric Balloon Dilatation in people with Delayed Gastric Emptying and Postoperative Nausea and Vomiting, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Delayed Gastric Emptying (DGE) (time frame: Up to 7 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.