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Not yet recruitingNCT07206004Updated Oct 3, 2025

Effect of Parenteral Support on FibroScan in Short Bowel Syndrome

An observational study in Short Bowel Syndrome, Intestinal Failure and Liver Diseases, sponsored by Rigshospitalet, Denmark. Not yet recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-03.

Sponsored by Rigshospitalet, Denmark · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2026, 3 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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.

Once 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.

Measurements will be performed:

  • Immediately before initiation of PS
  • Two hours after initiation of PS
  • Immediately after disconnection of PS
  • 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.
02

Conditions studied

  • Short Bowel Syndrome
  • Intestinal Failure
  • Liver Diseases

Keywords

  • FibroScan
  • transient elastography
  • parenteral nutrition
  • intestinal failure
  • hepatic fibrosis
03

In context

Short Bowel Syndrome

159 studies on the registry are indexed under Short Bowel Syndrome; 24 are open to participants now.

This study's planned enrollment of 20 is below the median of 53 across 36 observational studies indexed under Short Bowel Syndrome.

Browse Short Bowel Syndrome studies →

Lead sponsor

Rigshospitalet, Denmark is the lead sponsor of 1,007 studies on the registry; 175 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with short bowel syndrome receiving regular PS

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • Observational Cohort - patients with short bowel syndrome on parenteral support

    Patients will receive their ususal parenteral support during the study

    Diagnostic Test: Fibroscan

Interventions

  • Diagnostic testFibroscan

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

06

What researchers measure

Primary outcomes

  1. Fibroscran

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

    Time frame: 14 hours

Secondary outcomes

  1. CAP score

    Change in CAP score before, during, and after PS

    Time frame: 14 hours

  2. Correlation of Fibroscan and PS

    Correlation of changes in FibroScan values with PS composition and volume

    Time frame: 14 hours

  3. Correlation of Fibroscan and other factors

    Correlation with body weight, blood pressure, body fluid content, and urine output

    Time frame: 14 hours

07

Study locations

1 site
  • Department of Digestive Diseases, Transplantation and General Surgery, Rigshospitalet
    Copenhagen, Capital Region 2100, Denmark
08

References and documents

Publications

  • 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. PubMed 30947877 ↗
  • 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. PubMed 18973847 ↗
  • 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. PubMed 34453918 ↗
  • 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. PubMed 34295991 ↗
  • 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. PubMed 30976614 ↗
  • 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. PubMed 25769876 ↗
  • 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. PubMed 26430774 ↗
  • 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. PubMed 20022130 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07206004
Responsible party
Jessica Ramsing Wentworth (MD, Rigshospitalet, Denmark) — Principal investigator
First posted
Oct 3, 2025
Start date
Feb 2026 (estimated)
Primary completion
Aug 2026 (estimated)
Completion
Aug 2027 (estimated)
Last update
Oct 3, 2025

Study contacts

Jessica R Wentworth, MD
Contact
Jessica.jennifer.ramsing.wentworth@regionh.dk
+4521212254
Rahim M Naimi, MD, PhD
principal investigator · Rigshospitalet, Denmark

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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