Effect of Parenteral Support on FibroScan in Short Bowel Syndrome

Not yet recruiting

• Conditions: Short Bowel Syndrome; Intestinal Failure; Liver Diseases

• Registration Number: NCT07206004
• Lead Sponsor: Rigshospitalet, Denmark

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.

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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-25
• Study First Submitted QC: 2025-09-25
• Last Update Submitted: 2025-09-25
• Study First Posted: 2025-10-03
• Last Update Posted: 2025-10-03
• Study Start: 2026-02-01
• Primary Completion: 2026-08
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fibroscran	14 hours	Change in transient elastography (FibroScan) values before, during, and after parenteral support

Secondary Outcome Measures

Name	Time	Method
CAP score	14 hours	Change in CAP score before, during, and after PS
Correlation of Fibroscan and PS	14 hours	Correlation of changes in FibroScan values with PS composition and volume
Correlation of Fibroscan and other factors	14 hours	Correlation with body weight, blood pressure, body fluid content, and urine output

Trial Locations

Locations (1)

Department of Digestive Diseases, Transplantation and General Surgery, Rigshospitalet; 🇩🇰 Copenhagen, Capital Region, Denmark