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NCT Number: NCT07206004

Effect of Parenteral Support on FibroScan in Short Bowel Syndrome

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Digestive Diseases, Transplantation and General Surgery, Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

Location contact

Jessica R Wentworth, MD

CONTACT

[email protected]

+4521212254

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

FibroScan

Diagnostic Test

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

Primary outcomes

  1. Fibroscran

    Time frame: 14 hours

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

Secondary outcomes

  1. CAP score

    Time frame: 14 hours

    Change in CAP score before, during, and after PS

  2. Correlation of Fibroscan and PS

    Time frame: 14 hours

    Correlation of changes in FibroScan values with PS composition and volume

  3. Correlation of Fibroscan and other factors

    Time frame: 14 hours

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica R Wentworth, MD

CONTACT

[email protected]

+4521212254

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Effect of Parenteral Nutrition/Fluids on FibroScan Results in Patients With Short Bowel Syndrome

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Oct 3, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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