Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 7:39 PM
Study NCT ID:
NCT07451392
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-05
First Post:
2026-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraoperative Pyloric Balloon Dilatation to Reduce Delayed Gastric Emptying After PPPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018589', 'term': 'Gastroparesis'}, {'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], 'ancestors': [{'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D014839', 'term': 'Vomiting'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-28', 'studyFirstSubmitDate': '2026-02-28', 'studyFirstSubmitQcDate': '2026-02-28', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Delayed Gastric Emptying (DGE)', 'timeFrame': 'Up to 7 days postoperatively', 'description': "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."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Delayed Gastric Emptying', 'Pylorus-Preserving Pancreatoduodenectomy', 'PPPD', 'Pyloric Balloon Dilatation', 'Early Postoperative Vomiting', 'Pylorospasm'], 'conditions': ['Delayed Gastric Emptying', 'Postoperative Nausea and Vomiting', 'Gastric Emptying Time']}, 'descriptionModule': {'briefSummary': '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.\n\nParticipants 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.', 'detailedDescription': '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.\n\nThe 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.\n\nThis 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:\n\nIntervention 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.\n\nControl Group: Patients will undergo the standard PPPD procedure without any additional pyloric manipulation.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (≥18 years) scheduled for elective PPPD due to tumors of the pancreatic head, distal bile duct, or ampulla of Vater.\n* Patients with no prior history of gastric surgery or severe gastroparesis.\n* Patients with no contraindications to balloon dilatation or intraoperative endoscopic procedures\n\nExclusion Criteria:\n\n* Patients with prior gastric surgery, pyloric stenosis, or history of severe gastroparesis.\n* Patients with severe comorbidities that may preclude safe surgery (ASA class IV or higher).\n* Patients who require emergency surgery or have unresectable disease.\n* Patients with active gastrointestinal bleeding or severe malnutrition'}, 'identificationModule': {'nctId': 'NCT07451392', 'briefTitle': 'Intraoperative Pyloric Balloon Dilatation to Reduce Delayed Gastric Emptying After PPPD', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Intraoperative Pyloric Balloon Dilatation to Decrease Post PPPD Delayed Gastric Emptying. Does It Help? RCT Study', 'orgStudyIdInfo': {'id': 'Intraoperative Pyloric Balloon'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pyloric Dilatation', 'description': '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.', 'interventionNames': ['Procedure: Intraoperative Pyloric Balloon Dilatation']}, {'type': 'NO_INTERVENTION', 'label': 'No Pyloric Dilatation', 'description': 'No additional intervention will be performed at the pylorus. The standard PPPD procedure will be completed without balloon dilatation or any other pyloric manipulation.'}], 'interventions': [{'name': 'Intraoperative Pyloric Balloon Dilatation', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Pyloric Dilatation']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident at General Surgery Department, Assiut University', 'investigatorFullName': 'Taha Hussein Taha Hussein Khalil', 'investigatorAffiliation': 'Assiut University'}}}}