Effect of Parenteral Nutrition/Fluids on FibroScan Results in Patients With Short Bowel Syndrome
Conditions: Short Bowel Syndrome, Intestinal Failure, Liver Diseases
Sponsor: Rigshospitalet, Denmark

FibroScan and Parenteral Support – 
Protocol 
Version 2.0 – 10 July 2025 
Research Project Protocol 
Title: 
Effect of Parenteral Nutrition/Fluids on FibroScan Results in Patients with Short Bowel 
Syndrome 
Introduction 
Home Parenteral Support (HPS, nutrition and/or fluids) is a life-sustaining treatment for 
patients with short bowel syndrome and intestinal failure. Both HPS and short bowel 
syndrome may lead to complications, including hepatic dysfunction. Prolonged use of HPS 
can result in Intestinal Failure–Associated Liver Disease (IFALD), a heterogeneous condition 
that may include cholestasis, steatosis, and hepatic fibrosis, thereby increasing the risk of 
severe liver disease (1). Monitoring liver function in patients with intestinal failure 
receiving HPS is therefore essential. 
FibroScan, also known as transient elastography (TE), is a non-invasive, ultrasound-based 
method used to assess hepatic stiffness/fibrosis and steatosis (2). This technique has 
proven effective for excluding fibrosis (TE < 7 kPa) and for predicting clinically significant 
fibrosis in patients with other liver diseases, such as chronic hepatitis C (3). 
While it is well-documented that oral intake of food and fluids can influence TE results (4–
6), the impact of HPS has not been clearly elucidated. Previous studies in other patient 
populations, such as hemodialysis patients, have demonstrated that fluid overload may 
cause transient elevations in TE values (7). Similarly, a reversible increase in TE values has 
been observed with elevated intravenous pressure (8). These findings emphasize the need 
for specific research on how parenteral support (PS) affects TE measurements, particularly 
in patients receiving long-term intravenous therapy. 
The objective of this study is therefore 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. 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. 
The results of this study will contribute to the establishment of optimal protocols for 
FibroScan assessment in patients with intestinal failure and short bowel syndrome 
receiving PS. Ultimately, this will improve the accuracy of hepatic fibrosis monitoring in this 
patient population, as well as clinical decision-making and patient management in this 
complex field. 
Objectives 
To investigate the immediate effect of PS administration on FibroScan results in patients 
with short bowel syndrome, in order to determine the optimal timing of FibroScan 
assessments in this patient population. 
Methods 
Inclusion Criteria 
- Adult patients (≥18 years) with short bowel syndrome with capacity to give consent 
- Patients receiving regular PS, defined as administration on at least 4 days per week and a 
minimum of 10 liters of fluid per week 
- Patients in a stable clinical condition 
Exclusion Criteria 
- Patients with known liver cirrhosis 
- Patients with active infection, severe dehydration, or significant electrolyte disturbances 
- Pregnant patients 
- Patients receiving any form of intravenous fluids or medications on the day of the study 
procedure 
- Patients whose parenteral support is tapered with a reduced infusion rate prior to 
disconnection 
Study Design 
Open-label pilot study with a prospective observational design. 
Procedures 
If the participant has not had blood samples taken within 2 days prior to inclusion, blood 
tests equivalent to the department’s standard admission panel will be collected before 
inclusion to ensure that no exclusion criteria are met. Samples will be destroyed no later 
than 7 days after analysis. 

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. 
 
 
Patient Record Information 
Following informed consent and study inclusion, data will be obtained from medical 
records. Consent will allow the investigator and relevant authorities direct access to the 
patient’s medical record. Data will be used to evaluate secondary endpoints. The following 
information will be collected: 
- Age, sex, alcohol consumption (current and past) 
- HPS regimen (composition and volume) 
- Underlying disease leading to short bowel syndrome 
- Comorbidities 
- Current medication list 
- Most recent standard laboratory results prior to participation 
All personal data will be handled in compliance with the Danish Data Protection Act and the 
General Data Protection Regulation (GDPR). 
Endpoints 
Primary Endpoint 
- Change in TE (FibroScan value) before, during, and after HPS 

Secondary Endpoints 
- Change in CAP score (FibroScan value) before, during, and after HPS 
- Correlation between changes in FibroScan values and the volume/composition of HPS 
- Correlation between changes in FibroScan values and changes in body weight, blood 
pressure, body fluid content (measured by bioimpedance), and urine output 
- Patient-specific factors influencing changes in FibroScan values 
Participants 
Recruitment 
Participants will be recruited from patients admitted to the Department of Transplantation 
and Digestive Diseases, Rigshospitalet, and the associated outpatient clinic, where they 
receive lifelong follow-up. The principal investigator will identify potential participants 
during routine clinical practice. Patients who appear eligible based on inclusion and 
exclusion criteria will initially be asked by their treating physician whether they are willing 
to be contacted regarding the study. 
If the patient consents, the treating/principal investigator will provide the study team with 
the patient’s name and personal identification number. No additional information will be 
shared at this stage. A member of the study team will then contact the patient to provide 
further details about the study. 
Patients will be offered an informational meeting, either during hospitalization or in the 
outpatient clinic, where both verbal and written study information will be provided. 
Patients may have a companion present and are entitled to a minimum of 24 hours for 
consideration. Written informed consent will be obtained prior to participation. 
Sample Size 
A total of 20 patients with short bowel syndrome will be included. The sample size was 
calculated based on an expected change in TE of 1.5 kPa following PS, with an assumed 
standard deviation of residuals of 2 kPa. With a significance level of 5% and statistical 
power of 80%, the minimum sample size is 15 participants. To account for potential 
dropout and ensure adequate statistical power, 20 participants will be recruited. This 
number is considered feasible within a reasonable timeframe, given the rarity of short 
bowel syndrome. 
Data Analysis 
- Repeated Measures ANOVA, paired t-test, or Wilcoxon signed-rank test will be used to 
compare FibroScan values before and after PS administration. 
- Repeated Measures ANCOVA (multiple regression) will be used to identify factors 
influencing changes in FibroScan values. 

Ethical Considerations 
The study poses minimal risk to participants, as FibroScan and blood pressure 
measurement are non-invasive procedures. Mild discomfort may occur due to application of 
ultrasound gel on the abdomen and pressure from the FibroScan probe. Mild discomfort 
may also be experienced during blood pressure measurement. Blood sampling may cause 
minor pain, bruising, or infection, but no significant complications are anticipated. 
The study will be conducted in accordance with the Declaration of Helsinki and will be 
reviewed and approved by the Regional Committee on Health Research Ethics (Region 
Hovedstaden). Participants will be fully informed verbally and in writing, will be advised 
that participation is voluntary, and may withdraw at any time. Informed consent (both 
written and verbal) will be obtained prior to inclusion. 
The study will be registered with the Regional Committee on Health Research Ethics. No 
protocol-related activities will commence until written approval is obtained. The study will 
follow Good Clinical Practice (GCP) guidelines and comply with applicable data protection 
regulations. 
Financial Considerations 
Study participants will not receive financial compensation. The study is investigator-
initiated and not sponsored by industry. Neither the investigator nor project staff have 
financial ties to companies with interests in this study. Funding is provided by the 
Department of Transplantation and Gastroenterology, Rigshospitalet. 
Compensation 
The study is covered under Danish law regarding patient complaints and compensation 
within the healthcare system. 
Dissemination of Study Results 
Following completion of the study and statistical analysis, results will be submitted for 
publication in a peer-reviewed medical journal. Both positive, negative, and inconclusive 
findings will be published. Efforts will also be made to present the results at relevant 
scientific conferences. 

 
 
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