Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT03462602
Status:
UNKNOWN
Last Update Posted:
2018-03-12
First Post:
2018-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nasogastric Tube in Pancreatic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2021-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-05', 'studyFirstSubmitDate': '2018-02-26', 'studyFirstSubmitQcDate': '2018-03-05', 'lastUpdatePostDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to flatus', 'timeFrame': '24 months', 'description': "It's described as the time patients to get flatus after operation"}], 'secondaryOutcomes': [{'measure': 'Pulmonary complication', 'timeFrame': '24 months', 'description': 'It was confirmed by clinical symptoms and CXR'}, {'measure': 'Wound infection', 'timeFrame': '24 months', 'description': 'Superficial or deep surgical-site infections are both considered and should be reported in medical records. Superficial infections are considered when skin or subcutaneous tissue is involved, whereas deep infection is considered when extending into the fascial layer.'}, {'measure': 'Anastomotic leak', 'timeFrame': '24 months', 'description': 'Including any type of Anastomotic leak, pancreatic fistula, bile leakage, etc.'}, {'measure': 'Incisional hernia', 'timeFrame': '24 months', 'description': 'Hernia or separation that occurred through a surgical incision in the abdominal wall deriving either from laparotomy or trocar incisions. All available data will be considered from medical records.'}, {'measure': 'Length of Stay', 'timeFrame': '24 months', 'description': 'Define as the day after surgery to dismiss.'}, {'measure': 'Gastric upset', 'timeFrame': '24 months', 'description': 'Any symptoms described by the subjects.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nasogastric Tube Decompression', 'Pancreatic Surgery']}, 'descriptionModule': {'briefSummary': 'Introduction: The value of routine nasogastric tube (NGT) decompression after pancreatic surgeries is not yet established. Previous studies in the setting of abdominal surgery suggested that the use of NGT does not accomplish any of its intended goals.\n\nMethods/design: This is a prospective, randomized, controlled multicenter trial with two treatment arms. One group underwent pancreatic surgeries with routine NGT and was left in place after surgery until the patient passed flatus or stool. The other group underwent pancreatic surgeries without receiving NGT decompression, in which the NGT was removed at the end of surgery.\n\nDiscussion: Routine NGT decompression after pancreatic surgeries does or does not appear to have its anticipated advantages would be discovered in this RCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with age between 18 - 80 years.\n* Patients underwent any kind of pancreatic surgeries, including but not limited to PD, distal pancreatectomy, central pancreatectomy, pancreatic enucleation, etc.\n* Patients accepted the trial and could completed a written consent.\n\nExclusion Criteria:\n\n* Combined with digestive tract obstruction before the surgery.\n* History of upper abdominal surgery.\n* Serious heart, brain, lung, metabolic diseases history.\n* Pregnant women.\n* Unwillingness or inability to consent for the study.'}, 'identificationModule': {'nctId': 'NCT03462602', 'briefTitle': 'Nasogastric Tube in Pancreatic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'Randomized Clinical Trial for Evaluation of the Use of Nasogastric Tube Decompression After Pancreatic Surgery', 'orgStudyIdInfo': {'id': 'TJDBPS04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NGT group', 'description': 'NGT group', 'interventionNames': ['Procedure: NGT group']}, {'type': 'EXPERIMENTAL', 'label': 'non-NGT group', 'description': 'non-NGT group', 'interventionNames': ['Procedure: non-NGT group']}], 'interventions': [{'name': 'NGT group', 'type': 'PROCEDURE', 'description': 'After induction of anesthesia, a 14- or 16-Fr single-lumen NGT was placed in all patients. Its intragastric position was confirmed by intraoperative palpation. Randomization to the NGT or non-NGT group was performed on completion of surgery by computer-generated randomization provided by the supervision department.The NGT was retained until the return of bowel function (passage of flatus or passage of stool) in the patients assigned to the NGT group.', 'armGroupLabels': ['NGT group']}, {'name': 'non-NGT group', 'type': 'PROCEDURE', 'description': 'After induction of anesthesia, a 14- or 16-Fr single-lumen NGT was placed in all patients. Its intragastric position was confirmed by intraoperative palpation. Randomization to the NGT or non-NGT group was performed on completion of surgery by computer-generated randomization provided by the supervision department.The NGT was removed in the operation room immediately after the surgery in those assigned to the non-NGT group.', 'armGroupLabels': ['non-NGT group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430000', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Tongji Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Hang Zhang, doctor', 'role': 'CONTACT', 'email': 'okashiiyo@126.com', 'phone': '+8602783665314'}], 'overallOfficials': [{'name': 'Renyi Qin, pHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tongji Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical professor', 'investigatorFullName': 'Renyi Qin', 'investigatorAffiliation': 'Tongji Hospital'}}}}