Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-03-02 @ 9:26 AM
Study NCT ID:
NCT05879159
Status:
RECRUITING
Last Update Posted:
2025-10-24
First Post:
2023-05-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accelerated Recovery After MIS Hepatectomy (ARAMIS Hep) to Support Early Discharge for Patients Undergoing Minimally Invasive Liver Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-23', 'studyFirstSubmitDate': '2023-05-18', 'studyFirstSubmitQcDate': '2023-05-18', 'lastUpdatePostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0', 'timeFrame': 'through study completion; an average of 1 year.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'M D Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'To learn if an accelerated recovery program can shorten the length of hospital stay in patients having minimally invasive liver surgery.', 'detailedDescription': 'Primary Objectives:\n\nOur study will investigate the feasibility of an accelerated recovery program to minimize length of stay (LOS) and facilitate outpatient surgery for patients undergoing minimally invasive, lower complexity (Kawaguchi-Gayet grade I) liver resection. This program (ARAMIS Hep) will combine minimally invasive surgical (MIS) approaches (robotic OR laparoscopic), enhanced recovery after surgery (ERAS) protocols, and Telehealth to liberalize discharge criteria in a safe manner.\n\nSecondary Objectives:\n\nIn addition to demonstrating a reduction in LOS, our study will also provide preliminary data to aid in the broader implementation of this approach. Specifically, we will gain insight into the patient experience, measure patient-reported outcomes on recovery trajectories, and understand barriers to integrating a novel pathway into existing institutional frameworks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Tumor amenable to MIS Kawaguchi-Gayet grade I hepatectomy (see figure 1 below)\n* No evidence of cirrhosis (based on imaging, evidence of portal hypertension, clinical features, or laboratory results)\n* No significant cardiopulmonary disease that would prevent patients from undergoing MIS resection\n* Ability to stay within 50 miles of medical center for immediate postop period\n* Age of 18 years or above - because no adverse event data are currently available on enhanced recovery and early discharge after hepatic resection for patients \\<18 years of age, children are excluded from this study\n* Ability to understand and the willingness to sign a written informed consent document\n* Non-English-speaking patients are eligible for participation\n\nExclusion Criteria:\n\nPatients who will be excluded include those with:\n\n* Tumors NOT amenable to MIS Kawaguchi-Gayet grade I hepatectomy\n* Tumors not amenable to MIS or Robotic-assisted surgical resection\n* Evidence of Cirrhosis on imaging, clinically, or lab testing\n* Inability to stay within 50 miles of the Cancer Center in the immediate post-operative period\n* Age below 18 years\n* Inability to consent for trial/protocol\n* Patients who are pregnant'}, 'identificationModule': {'nctId': 'NCT05879159', 'briefTitle': 'Accelerated Recovery After MIS Hepatectomy (ARAMIS Hep) to Support Early Discharge for Patients Undergoing Minimally Invasive Liver Resection', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Accelerated Recovery After MIS Hepatectomy (ARAMIS Hep) to Support Early Discharge for Patients Undergoing Minimally Invasive Liver Resection', 'orgStudyIdInfo': {'id': '2022-0917'}, 'secondaryIdInfos': [{'id': 'NCI-2023-04169', 'type': 'OTHER', 'domain': 'NCI-CTRP Clinical Trials Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Accelerated Recovery Protocol', 'description': 'Accelerated Recovery after Minimally Invasive Hepatic Surgery (ARAMIS-Hep)\n\nParticipants randomized to this arm will undergo a recovery pathway that potentially allows for discharge on the day of surgery (post-operative day 0).\n\n* You will receive a clear liquid diet, be encouraged to ambulate independently, and opioid use will be minimized in the recovery unit.\n* You will be assessed in the post-operative recovery unit. If you meet discharge criteria, you will be discharged the afternoon/evening of surgery. If you do not, you will be admitted for overnight observation.\n* You will have a telehealth video visit on post-operative days 1 and 2\n* You will have in-person clinic visit within 14 days of discharge.\n\nYou will fill out about 14 questionnaires over a 30-day period to assess how you are feeling regarding your recovery', 'interventionNames': ['Behavioral: Questionnaires']}, {'type': 'EXPERIMENTAL', 'label': 'Comparison/Control Arm', 'description': 'Standard Post-operative recovery pathway after minimally invasive hepatic surgery.\n\nParticipants randomized to this arm will undergo our institution\'s standard recovery pathway for minimally invasive liver surgery.\n\n* You will be transferred to the Transitional PACU for overnight observation.\n* Your diet will be advanced to gastrointestinal "first food" diet on Post-operative Day 1, with opioid weaning and frequent ambulation.\n* You will be discharged once criteria are met.\n* You will have an in-person clinic visit within 14 days of discharge.\n\nYou will fill out about 14 questionnaires over a 30-day period to assess how you are feeling regarding your recovery.', 'interventionNames': ['Behavioral: Questionnaires']}], 'interventions': [{'name': 'Questionnaires', 'type': 'BEHAVIORAL', 'description': 'Survey', 'armGroupLabels': ['Accelerated Recovery Protocol', 'Comparison/Control Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hop Tran Cao, MD', 'role': 'CONTACT', 'email': 'hstran@mdanderson.org', 'phone': '713-745-4670'}, {'name': 'Hop Tran Cao, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Hop Tran Cao, MD', 'role': 'CONTACT', 'email': 'hstran@mdanderson.org', 'phone': '(713) 745-4670'}], 'overallOfficials': [{'name': 'Hop Tran Cao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Intuitive Surgical Inc', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}