Effect of Parenteral Support on FibroScan in Short Bowel Syndrome

NCT07206004 | Not Yet Recruiting

• 1 other identifier: H-25037724
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Short Bowel Syndrome; Intestinal Failure; Liver Diseases

Keywords

FibroScan; transient elastography; parenteral nutrition; intestinal failure; hepatic fibrosis

Outcome Measures

Primary Outcomes (1)

• Fibroscran

  Change in transient elastography (FibroScan) values before, during, and after parenteral support

  14 hours

Secondary Outcomes (3)

• CAP score

  14 hours

• Correlation of Fibroscan and PS

  14 hours

• Correlation of Fibroscan and other factors

  14 hours

Study Arms (1)

Observational Cohort - patients with short bowel syndrome on parenteral support

Patients will receive their ususal parenteral support during the study

Diagnostic Test: Fibroscan

Interventions

Fibroscan DIAGNOSTIC_TEST

Fibroscan will be perfomed while the patient receives their usual parenteral support

Observational Cohort - patients with short bowel syndrome on parenteral support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with short bowel syndrome receiving regular PS

You may qualify if:

• Adult patients (≥18 years) with short bowel syndrome with capacity to give consent
• Patients receiving regular PS (≥4 days/week and ≥10 liters/week)
• Stable clinical condition

You may not qualify if:

• Known liver cirrhosis
• Active infection, severe dehydration, or electrolyte disturbances
• Pregnancy
• Receiving IV fluids or medications on study day
• Tapered infusion rate prior to disconnection

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Department of Digestive Diseases, Transplantation and General Surgery, Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

Location

Related Publications (8)

• 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: 30947877 BACKGROUND

• 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: 18973847 BACKGROUND

• 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: 34453918 BACKGROUND

• 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: 34295991 BACKGROUND

• 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: 30976614 BACKGROUND

• 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: 25769876 BACKGROUND

• 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: 26430774 BACKGROUND

• 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.

  PMID: 20022130 BACKGROUND

MeSH Terms

Conditions

Short Bowel Syndrome; Intestinal Failure; Liver Diseases; Hyperphagia; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms; Fibrosis

Study Officials

• Rahim M Naimi, MD, PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica R Wentworth, MD

CONTACT

+4521212254; Jessica.jennifer.ramsing.wentworth@regionh.dk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: October 3, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)