Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-02-20 @ 8:26 PM
Study NCT ID:
NCT02594956
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2015-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of the Absence of Nasogastric Decompression After Pancreaticoduodenectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004750', 'term': 'Enteral Nutrition'}], 'ancestors': [{'id': 'D005248', 'term': 'Feeding Methods'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D018529', 'term': 'Nutritional Support'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-11', 'studyFirstSubmitDate': '2015-10-29', 'studyFirstSubmitQcDate': '2015-10-30', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of Clavien and Dindo complication ≥ grade II', 'timeFrame': 'up to five days after surgery', 'description': 'during hospitalisation to demonstrate the feasibility of the absence of NG decompression after pancreaticoduodenectomy'}], 'secondaryOutcomes': [{'measure': 'Pulmonary complication', 'timeFrame': 'up to 90 days after surgery', 'description': 'occurrence of pulmonary complication (including atelectasic, pleural effusion, pneumonitis'}, {'measure': 'Gastric emptying', 'timeFrame': 'up to five days after surgery', 'description': 'occurrence of gastric delayed emptying (classified to the ISGPS classification )'}, {'measure': 'Pancreatic fistula', 'timeFrame': 'up to 90 days after surgery', 'description': 'Occurence of pancreatic fistula (classified according to the ISGPS classification)'}, {'measure': 'Food intake', 'timeFrame': 'up to five days after surgery', 'description': 'Time to oral food intake'}, {'measure': 'First gas', 'timeFrame': 'up to five days after surgery', 'description': 'Time to the emission of the first gas'}, {'measure': 'Reinsertion of Nasogastric tube', 'timeFrame': 'up to five days after surgery', 'description': 'NG tube reinsertion rate'}, {'measure': 'Reinsertion of Nasogastric tube', 'timeFrame': 'up to five days after surgery', 'description': 'NG tube reinsertion time'}, {'measure': 'Reinsertion of Nasogastric tube', 'timeFrame': 'up to five days after surgery', 'description': 'NG tube reinsertion for gastroparesis or reintubation'}, {'measure': 'Mortality rate', 'timeFrame': 'up to 90 days after surgery'}, {'measure': 'Hospital stay', 'timeFrame': 'up to 90 days after surgery', 'description': 'length of hospital stay'}, {'measure': 'Readmission rate', 'timeFrame': 'up to 90 days after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['nasogastric decompression'], 'conditions': ['Digestive System Surgical Procedure', 'Pancreaticoduodenectomy']}, 'referencesModule': {'references': [{'pmid': '32667635', 'type': 'DERIVED', 'citation': 'Bergeat D, Merdrignac A, Robin F, Gaignard E, Rayar M, Meunier B, Beloeil H, Boudjema K, Laviolle B, Sulpice L. Nasogastric Decompression vs No Decompression After Pancreaticoduodenectomy: The Randomized Clinical IPOD Trial. JAMA Surg. 2020 Sep 1;155(9):e202291. doi: 10.1001/jamasurg.2020.2291. Epub 2020 Sep 16.'}]}, 'descriptionModule': {'briefSummary': 'The use of nasogastric (NG) decompression after pancreaticoduodenectomy (PD) is a current practice. NG tube is associated with a high rate of morbidity including pulmonary morbidity, delayed gastric emptying and finally an increased length of hospital stay.\n\nThe absence of NG decompression could be the corner stone of the concept of the enhanced recovery program after PD.', 'detailedDescription': 'The use of nasogastric (NG) decompression after pancreaticoduodenectomy (PD) is a current practice. NG tube is associated with a high rate of morbidity including pulmonary morbidity, delayed gastric emptying and finally an increased length of hospital stay. In the era of the enhance recovery after major abdominal surgery, the place of the NG tube remains unproven after PD even if NG tube is clearly abandoned in liver, stomach and colonic surgery. Nowadays, only few retrospective series had reported the feasibility of the absence of nasogastric tube after PD, but not with a randomized control trial. The absence of NG decompression could be the corner stone of the concept of the enhanced recovery program after PD.\n\nThe objective of this prospective randomized monocentric study is to evaluate the impact of the absence of NG decompression after PD.\n\nThe aim of the study is to decrease postoperative morbidity after PD including pulmonary and delayed gastric emptying complication. The impact of the absence of systematic NG decompression could be interesting in terms of public health with a decreased of length of hospital stay. Furthermore, this is the first randomized study comparing NG tube decompression after PD to absence of NG tube after PD which would bring relevant elements to improve the recovery after PD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years and ≤ 75 years\n* patient requiring a PD for benign of malign pathology of the bilio and pancreatic intersection\n* patient giving free and informed consent\n\nExclusion Criteria:\n\n* previous gastric of esophagus surgery\n* sever comorbidity such as : end stage renal disease, respiratory failure, heart failure (≥ 3 NYHA)\n* Person with a measure of legal protection (guardianship)\n* Pregnant woman or nursing mother'}, 'identificationModule': {'nctId': 'NCT02594956', 'acronym': 'IPOD', 'briefTitle': 'Impact of the Absence of Nasogastric Decompression After Pancreaticoduodenectomy', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Impact of the Absence of Nasogastric Decompression After Pancreaticoduodenectomy : A Prospective and Randomized Study', 'orgStudyIdInfo': {'id': 'RennesUH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'With Nasogastric Decompression', 'description': 'This group will receive conventional care according to the protocol of the service in place with removal of the nasogastric tube the 3rd postoperative day if the flow is \\< 500ml / 24h, if not removal will take place on the 5th postoperative day.', 'interventionNames': ['Device: nasogastric tube']}, {'type': 'EXPERIMENTAL', 'label': 'Without Nasogastric decompression', 'description': 'The nasogastric tube will be take off at the end of the surgery, just after the extubation.', 'interventionNames': ['Device: no nasogastric tube']}], 'interventions': [{'name': 'no nasogastric tube', 'type': 'DEVICE', 'otherNames': ['no double lumen nasogastric tube'], 'armGroupLabels': ['Without Nasogastric decompression']}, {'name': 'nasogastric tube', 'type': 'DEVICE', 'otherNames': ['double lumen nasogastric tube'], 'armGroupLabels': ['With Nasogastric Decompression']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35000', 'city': 'Rennes', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire Rennes Pontchaillou', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'overallOfficials': [{'name': 'Laurent Sulpice, MD/PH/prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rennes UH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}