Ignite Creation Date:
2025-12-24 @ 4:30 PM
Ignite Modification Date:
2026-01-04 @ 5:37 AM
Study NCT ID:
NCT04742166
Status:
UNKNOWN
Last Update Posted:
2023-07-28
First Post:
2021-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Side to Side Gastrojejunostomy on the Rate of Delayed Gastric Emptying After Pancreaticoduodenectomy (IPAD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019651', 'term': 'Plastic Surgery Procedures'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 166}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-27', 'studyFirstSubmitDate': '2021-02-04', 'studyFirstSubmitQcDate': '2021-02-04', 'lastUpdatePostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative delayed gastric emptying', 'timeFrame': 'Day 90', 'description': 'Occurrence of post-operative delayed gastric emptying (classified to the International Study Group for Pancreatic Surgery (ISGPS))'}], 'secondaryOutcomes': [{'measure': 'Occurrence of Clavien-Dindo complications', 'timeFrame': 'Up to day 90'}, {'measure': 'Pancreatic fistula', 'timeFrame': 'Up to day 90', 'description': 'Occurence of pancreatic fistula (classified according to the ISGPS classification)'}, {'measure': 'Biliary fistula', 'timeFrame': 'Up to day 90', 'description': 'Occurrence of biliary fistula'}, {'measure': 'Haemorrhage', 'timeFrame': 'Up to day 90', 'description': 'Occurrence of haemorrhage according to the ISGPS classification'}, {'measure': 'Food intake (liquid and solid)', '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': 'Pre-operative to 3-month post-operative weight ratio', 'timeFrame': 'Up to day 90'}, {'measure': 'Albumin and prealbumin levels', 'timeFrame': 'Up to day 90'}, {'measure': 'General Quality of Life Score for Digestive Pathologies', 'timeFrame': 'Up to day 90'}, {'measure': 'Gastrointestinal Quality of Life Index (GIQLI)', 'timeFrame': 'Up to day 90'}, {'measure': 'Mortality rate', 'timeFrame': 'Day 30'}, {'measure': 'Mortality rate', 'timeFrame': 'Day 90'}, {'measure': 'Time to functional recovery (days) after surgery', 'timeFrame': 'Day 90', 'description': 'Functional recovery defined as all of the following:\n\n* independently mobile at the preoperative level\n* sufficient pain control with oral medication alone\n* ability to maintain at least 50% daily required caloric intake\n* no intravenous fluid administration\n* no clinical signs of infection when other criteria were met'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgical Technique']}, 'descriptionModule': {'briefSummary': 'Prospective bi-centric randomized open-label study comparing side to side and end to side gastrojejunostomy in pancreaticoduodenectomy', 'detailedDescription': "Delayed gastric emptying is one of the main complications occurring after pancreatodudodenectomy, the incidence of which is estimated between 10 and 40% in the literature. Its occurrence leads to an alteration in post-operative quality of life (maintenance or resting of the nasogastric tube) and is the primary reason an increase in the length of hospital stay and therefore the cost of treatment. In addition, it predisposes to the risk of inhalation pneumopathy, which increases the risk of post-operative death. Various technical surgical points have been suggested by retrospective studies to reduce its incidence (pyloric preservation, respect for the left gastric vein, ante-colic positioning of the Child's handle, making a Y-shaped handle) but without ever being validated in randomized prospective studies.\n\nRecently three retrospective studies have highlighted the interest of performing a side to side l rather than an end to side gastro-jejunal anastomosis to reduce the rate of post-operative delayed gastric emptying."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient over 18 years old\n* to benefit from a cephalic duodenopancreatectomy whatever the indication (benign and malignant tumor)\n* affiliated with a health insurance system\n* having received oral and written information about the protocol and having signed a free and informed written consent.\n\nExclusion Criteria:\n\n* associated organ resection except for portal vein or hepatic artery resection.\n* history of gastric or esophageal resection\n* person subject to legal protection (safeguard justice, trusteeship and guardianship) and persons deprived of liberty\n* pregnant or breastfeeding women\n* patient participating in another clinical trial that may interfere with the protocol.'}, 'identificationModule': {'nctId': 'NCT04742166', 'acronym': 'IPAD', 'briefTitle': 'Impact of Side to Side Gastrojejunostomy on the Rate of Delayed Gastric Emptying After Pancreaticoduodenectomy (IPAD)', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Impact of Side to Side Gastrojejunostomy on the Rate of Delayed Gastric Emptying After Pancreaticoduodenectomy: A Prospective Randomized Study', 'orgStudyIdInfo': {'id': '35RC20_8891_IPAD Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Side to side gastrojejunal reconstruction', 'description': 'The post-operative care: usual practise Follow-up: 90 days postoperatively\n\nAt Day 90:\n\n* a blood test for albumin and prealbumin\n* a GIQLI questionnaire (quality of life score) to be completed by the patient', 'interventionNames': ['Procedure: Reconstruction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Terminolateral gastrojejunal reconstruction', 'description': 'The post-operative care: usual practise Follow-up: 90 days postoperatively\n\nAt Day 90:\n\n* a blood test for albumin and prealbumin\n* a GIQLI questionnaire (quality of life score) to be completed by the patient', 'interventionNames': ['Procedure: Reconstruction']}], 'interventions': [{'name': 'Reconstruction', 'type': 'PROCEDURE', 'description': 'Lateral gastrojejunal Terminolateral gastrojejunal', 'armGroupLabels': ['Side to side gastrojejunal reconstruction', 'Terminolateral gastrojejunal reconstruction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13009', 'city': 'Marseille', 'country': 'France', 'facility': 'Institut Paoli Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'CHU de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}