Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT07206004
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-03
First Post:
2025-09-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Parenteral Support on FibroScan in Short Bowel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012778', 'term': 'Short Bowel Syndrome'}, {'id': 'D000090124', 'term': 'Intestinal Failure'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D006963', 'term': 'Hyperphagia'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D005355', 'term': 'Fibrosis'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-07-10', 'size': 266374, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-09-25T08:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2025-09-25', 'studyFirstSubmitQcDate': '2025-09-25', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fibroscran', 'timeFrame': '14 hours', 'description': 'Change in transient elastography (FibroScan) values before, during, and after parenteral support'}], 'secondaryOutcomes': [{'measure': 'CAP score', 'timeFrame': '14 hours', 'description': 'Change in CAP score before, during, and after PS'}, {'measure': 'Correlation of Fibroscan and PS', 'timeFrame': '14 hours', 'description': 'Correlation of changes in FibroScan values with PS composition and volume'}, {'measure': 'Correlation of Fibroscan and other factors', 'timeFrame': '14 hours', 'description': 'Correlation with body weight, blood pressure, body fluid content, and urine output'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['FibroScan', 'transient elastography', 'parenteral nutrition', 'intestinal failure', 'hepatic fibrosis'], 'conditions': ['Short Bowel Syndrome', 'Intestinal Failure', 'Liver Diseases']}, 'referencesModule': {'references': [{'pmid': '30947877', 'type': 'BACKGROUND', 'citation': 'Pironi L, Sasdelli AS. Intestinal Failure-Associated Liver Disease. Clin Liver Dis. 2019 May;23(2):279-291. doi: 10.1016/j.cld.2018.12.009. Epub 2019 Feb 21.'}, {'pmid': '18973847', 'type': 'BACKGROUND', 'citation': 'de Ledinghen V, Vergniol J. Transient elastography (FibroScan). Gastroenterol Clin Biol. 2008 Sep;32(6 Suppl 1):58-67. doi: 10.1016/S0399-8320(08)73994-0.'}, {'pmid': '34453918', 'type': 'BACKGROUND', 'citation': 'Gu C, Wang H, Shu J, Zheng J, Li D, Cai C, Zhang P. RNA sequencing combining with whole exome sequencing reveals a compound heterozygous variant in ATM in a girl with atypical ataxia-telangiectasia. Clin Chim Acta. 2021 Dec;523:6-9. doi: 10.1016/j.cca.2021.08.026. Epub 2021 Aug 25.'}, {'pmid': '34295991', 'type': 'BACKGROUND', 'citation': 'Lee J, Lee R, Erpelding T, Siddoway RL, Gao J. The effect of water intake on ultrasound tissue characteristics and hemodynamics of adult livers. Clin Exp Hepatol. 2021 Jun;7(2):223-230. doi: 10.5114/ceh.2021.107068. Epub 2021 Jun 30.'}, {'pmid': '30976614', 'type': 'BACKGROUND', 'citation': 'Silva M, Costa Moreira P, Peixoto A, Santos AL, Lopes S, Goncalves R, Pereira P, Cardoso H, Macedo G. Effect of Meal Ingestion on Liver Stiffness and Controlled Attenuation Parameter. GE Port J Gastroenterol. 2019 Mar;26(2):99-104. doi: 10.1159/000488505. Epub 2018 Apr 20.'}, {'pmid': '25769876', 'type': 'BACKGROUND', 'citation': 'Alvarez D, Orozco F, Mella JM, Anders M, Antinucci F, Mastai R. Meal ingestion markedly increases liver stiffness suggesting the need for liver stiffness determination in fasting conditions. Gastroenterol Hepatol. 2015 Aug-Sep;38(7):431-5. doi: 10.1016/j.gastrohep.2015.01.009. Epub 2015 Mar 11.'}, {'pmid': '26430774', 'type': 'BACKGROUND', 'citation': 'Khunpakdee N, Jayanama K, Kaewdoung P, Promson K, Rattanasiri S, Warodomwichit D, Kantachuvesiri S, Sobhonslidsuk A. Transient Elastography in End-Stage Renal Disease Patients on Hemodialysis: The Effect of Net Fluid Withdrawal. Blood Purif. 2015;40(3):256-9. doi: 10.1159/000439582. Epub 2015 Oct 3.'}, {'pmid': '20022130', 'type': 'BACKGROUND', 'citation': 'Millonig G, Friedrich S, Adolf S, Fonouni H, Golriz M, Mehrabi A, Stiefel P, Poschl G, Buchler MW, Seitz HK, Mueller S. Liver stiffness is directly influenced by central venous pressure. J Hepatol. 2010 Feb;52(2):206-10. doi: 10.1016/j.jhep.2009.11.018. Epub 2009 Dec 4.'}]}, 'descriptionModule': {'briefSummary': 'Home Parenteral Support (HPS) is a life-sustaining treatment for patients with short bowel syndrome and intestinal failure. This study aims to investigate how administration of parenteral support affects FibroScan results in order to determine optimal timing of liver assessment in this patient population.', 'detailedDescription': 'The objective of this study is to investigate the applicability and accuracy of FibroScan in assessing liver status among patients with short bowel syndrome and intestinal failure, both before and after administration of PS, by assessing the immediate effect of PS administration on FibroScan results in patients with short bowel syndrome. This is of particular importance since the timing of FibroScan relative to PS administration and infusion volume is presumed to influence the results, and thereby potentially the interpretation of hepatic status.By understanding how parenteral support influences FibroScan measurements, we aim to optimize the use of this non-invasive technique for monitoring liver status in patients with intestinal failure, thereby defining the optimal timing of scanning in relation to PS administration. This could potentially enable earlier detection of hepatic complications and thereby improve the long-term prognosis for these patients.\n\nOnce included, participants must fast and abstain from fluids for 3 hours prior to the examination. Measurements will consist of a FibroScan, blood pressure, body weight, and bioimpedance analysis.\n\nMeasurements will be performed:\n\n* Immediately before initiation of PS\n* Two hours after initiation of PS\n* Immediately after disconnection of PS\n* Two hours after completion of PS Participants will collect urine from 0 to 14 hours. Spot urine sodium will be analyzed at 0 hours and 14 hours. Urine volume will be measured and then discarded. The standard infusion time for PS is set at 12 hours overnight.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with short bowel syndrome receiving regular PS', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (≥18 years) with short bowel syndrome with capacity to give consent\n* Patients receiving regular PS (≥4 days/week and ≥10 liters/week)\n* Stable clinical condition\n\nExclusion Criteria:\n\n* Known liver cirrhosis\n* Active infection, severe dehydration, or electrolyte disturbances\n* Pregnancy\n* Receiving IV fluids or medications on study day\n* Tapered infusion rate prior to disconnection'}, 'identificationModule': {'nctId': 'NCT07206004', 'briefTitle': 'Effect of Parenteral Support on FibroScan in Short Bowel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Effect of Parenteral Nutrition/Fluids on FibroScan Results in Patients With Short Bowel Syndrome', 'orgStudyIdInfo': {'id': 'H-25037724'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational Cohort - patients with short bowel syndrome on parenteral support', 'description': 'Patients will receive their ususal parenteral support during the study', 'interventionNames': ['Diagnostic Test: Fibroscan']}], 'interventions': [{'name': 'Fibroscan', 'type': 'DIAGNOSTIC_TEST', 'description': 'Fibroscan will be perfomed while the patient receives their usual parenteral support', 'armGroupLabels': ['Observational Cohort - patients with short bowel syndrome on parenteral support']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'state': 'Capital Region', 'country': 'Denmark', 'contacts': [{'name': 'Jessica R Wentworth, MD', 'role': 'CONTACT', 'email': 'Jessica.jennifer.ramsing.wentworth@regionh.dk', 'phone': '+4521212254'}], 'facility': 'Department of Digestive Diseases, Transplantation and General Surgery, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Jessica R Wentworth, MD', 'role': 'CONTACT', 'email': 'Jessica.jennifer.ramsing.wentworth@regionh.dk', 'phone': '+4521212254'}], 'overallOfficials': [{'name': 'Rahim M Naimi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Jessica Ramsing Wentworth', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}