Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2025-12-27 @ 10:15 PM
Study NCT ID:
NCT07017361
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-17
First Post:
2025-05-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ERAS Program Implementation for MIPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003226', 'term': 'Congresses as Topic'}], 'ancestors': [{'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-06-03', 'size': 460499, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-06-03T05:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-14', 'studyFirstSubmitDate': '2025-05-20', 'studyFirstSubmitQcDate': '2025-06-03', 'lastUpdatePostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants Meeting Discharge Criteria by Post-operative Day 5 Afternoon', 'timeFrame': 'Up to the afternoon of Post-operative Day 5'}], 'secondaryOutcomes': [{'measure': 'Length of Post-operative Hospital Stay (Days)', 'timeFrame': 'Post-operative Day 0 until hospital discharge (assessed up to Post-operative Day 30)'}, {'measure': 'Incidence of Major Complications (Clavien-Dindo ≥ Grade IIIa) Within 30 Days', 'timeFrame': 'Post-operative Day 0 to Day 30'}, {'measure': 'Total Direct Medical Costs per Participant (KRW) During Index Hospitalization', 'timeFrame': 'Post-operative Day 0 until hospital discharge (assessed up to Post-operative Day 30)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pancreaticoduodenectomy', 'ERAS', 'Minimally Invasive Surgery'], 'conditions': ['Pancreaticoduodenectomy', 'ERAS', 'Minimally Invasive Surgery']}, 'descriptionModule': {'briefSummary': 'To evaluate the impact of an Enhanced Recovery After Surgery (ERAS) program on postoperative recovery in patients undergoing minimally invasive pancreatoduodenectomy (MIPD)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 19 years, scheduled for standard minimally invasive (robotic or laparoscopic) pancreatoduodenectomy for periampullary tumors\n* ECOG performance status of 0 or 1 at screening\n* Able to provide written informed consent, understand study procedures, and complete patient-reported questionnaires\n* ASA physical status classification I-III\n\nExclusion Criteria:\n\n* Hypersensitivity to fentanyl or ropivacaine\n* Cognitive impairment preventing independent use of patient-controlled analgesia or completion of questionnaires\n* Major internal medical or psychiatric disorders affecting treatment response\n* Severe hepatic or renal dysfunction\n* Any condition deemed inappropriate for study participation by the investigator'}, 'identificationModule': {'nctId': 'NCT07017361', 'briefTitle': 'ERAS Program Implementation for MIPD', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Multicenter Randomized Prospective Study on Establishing an ERAS Program and Optimized Clinical Protocol for Patients Undergoing Minimally Invasive Pancreatoduodenectomy (MIPD)', 'orgStudyIdInfo': {'id': 'H-2502-154-1619'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional', 'interventionNames': ['Procedure: Conventional']}, {'type': 'EXPERIMENTAL', 'label': 'ERAS', 'interventionNames': ['Procedure: ERAS']}], 'interventions': [{'name': 'Conventional', 'type': 'PROCEDURE', 'description': 'Pre-operative fasting: NPO for solids and fluids from 00:00. No pre-emptive oral analgesia. Intra-operative: IV dexamethasone 5 mg at anaesthesia induction; IV acetaminophen 1 g about 1 h before wound closure. Post-operative nutrition: Levin tube removed in OR. POD1 morning-sips of water; POD3 morning upright abdominal X-ray; if normal, start soft fluid diet POD3 evening. POD4 pancreatobiliary CT; if normal, start soft bland diet at lunch. Drain management: two drains at hepaticojejunostomy and pancreaticojejunostomy; drain amylase measured POD1, 3 and 5; if POD4 CT normal, drains removable from POD5 per surgeon discretion (output, fever, pain). Analgesia: IV PCA until ≈POD3, then oral acetaminophen 650 mg every 8 h. No carbohydrate loading or NSAID/nefopam adjuncts.', 'armGroupLabels': ['Conventional']}, {'name': 'ERAS', 'type': 'PROCEDURE', 'description': 'Pre-op fasting: solids NPO from 00:00; clear fluids until 3 h pre-op; 300 mL carbohydrate drink 2-4 h pre-op with oral acetaminophen 650 mg + zaltoprofen 80 mg. Intra-op: IV dexamethasone 8 mg at induction; IV acetaminophen 1 g + ibuprofen 300 mg + nefopam 20 mg 1 h before closure. Post-op nutrition: Levin tube removed in OR. POD1 sips of water; POD2 morning upright abdominal X-ray-if normal, start soft fluid diet POD2 evening. POD3 pancreatobiliary CT-if normal, start soft bland diet at lunch. Drain mgmt: same placement; amylase POD1 \\& 3; if POD4 CT normal and amylase ≤ 5 000 U/L trending down, remove drains POD4; otherwise per surgeon. Analgesia: IV PCA until ≈POD3; until POD1 morning, IV acetaminophen 1 g + ibuprofen 300 mg q8h; POD1-5, oral acetaminophen 650 mg + zaltoprofen 80 mg q8h.', 'armGroupLabels': ['ERAS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Daehak-ro, Jongno-gu', 'state': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Hyo-Jin Lee', 'role': 'CONTACT', 'email': 'ash0324@snu.ac.kr', 'phone': '+821039538452'}], 'facility': 'Seoul National University Hospital'}], 'centralContacts': [{'name': 'Young Jae Cho, M.D.', 'role': 'CONTACT', 'email': 'whdudwo85@naver.com', 'phone': '+821023783631'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'SMG-SNU Boramae Medical Center', 'class': 'OTHER'}, {'name': 'Korea University Anam Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Wooil Kwon', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}