Water-Soluble Contrast Induced Intestinal Stimulation for the Treatment of Small Bowel Obstruction: A Feasibility Study

The Use of Nasogastric Tubes and Water-Soluble Contrast With or Without Radiographic Imaging in The Management of Adhesive Small Bowel Obstruction: A Feasibility Study

Small bowel obstruction (SBO) is common yet, how to best manage it remains unknown. One approach is to administer water soluble oral contrast (WSC) and the obtain x-rays to determine how well the bowel is functioning. WSC may help resolve SBO by stimulating the bowel by itself. The intent of this study is to determine if the x-ray component of this therapeutic approach is necessary.

Study Overview

• Status: Not yet recruiting
• Conditions: Small Bowel Obstruction
• Intervention / Treatment: Diagnostic test: Abdominal Radiography

Detailed Description

Responsible for more than 340,000 hospital admissions per year, small bowel obstruction (SBO) is one of the most common causes of serious gastrointestinal disease in the US. Adhesion-related SBO (aSBO) is usually treated by the placement of a nasogastric tube (NGT) to decompress the stomach, administration of intravenous (IV) fluids and observation by a surgical team. In most (60%) patients, aSBO resolves spontaneously. However, NGTs are uncomfortable for patients and have multiple associated risks, leading many patients and clinicians to avoid their use if possible.

Despite NGT placement being considered a standard component of aSBO treatment, some series report that as many as ½ of all patients with aSBO may be treated without them. A recent meta-analysis showed that hospital length-of-stay (HLOS) may be reduced by 2 days if treated with water-soluble contrast (WSC).

Despite aSBO being common, little is known about the optimal means for its treatment and even less about the mechanisms by which it resolves. The overall intent of this research is to develop evidence-based treatment protocols and to better understand the mechanisms by which aSBO resolves and how interventions can be developed to improve its treatment.

This feasibility study's purpose is to determine the ability to perform a randomized clinical trial (RCT) investigating treatments options for aSBO. Specifically, WSC will be administered to patients with a SBO followed by randomization to undergo formal upper gastrointestinal-small bowel follow through (UGI-SBFT) series vs no radiologic imaging to determine if radiologic examination can be eliminated when treating patients with aSBO. A concurrent observational arm will enroll patients who elect not to have NGTs placed to follow their hospital course. A state-transition model of daily clinical status will be tested to determine its effectiveness as a primary outcome to replace older, traditional outcomes for hospitalized patients such as diet resumption or length of stay.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Edward H Livingston, MD; Phone Number: 818-461-3321; Email: elivingston@mednet.ucla.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Documentation of aSBO as evidenced by one or more clinical features meeting the following criteria:

   • Nausea
   • Emesis
   • Abdominal pain
   • Distended abdomen
   • CT evidence of aSBO
   • Known abdominal surgical history.
2. Written informed consent obtained from subject.

Exclusion Criteria:

1. Unable to provide consent for the study.
2. Pregnant or breastfeeding.
3. Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
4. Unstable angina or recent myocardial infarction or stroke within 6 months
5. Patients with peritonitis or who require immediate surgery.

6. Non-adhesive SBO, including.

   • Paralytic Ileus
   • Incarcerated hernia
   • Fecal impaction
   • Intra-abdominal malignancy
   • Early aSBO within 4 weeks of a prior abdominal operation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Imaging; Patients with SBO will undergo an initial WSC study but no subsequent x-rays will be obtained,	Diagnostic test: Abdominal Radiography; Obtain plain film radiographs 3 times after adminstration of WSC
Active Comparator: Control; Patients with SBO will undergo an initial WSC study and will have routine abdominal radiographs at 12, 24, and 48 hours.	Diagnostic test: Abdominal Radiography; Obtain plain film radiographs 3 times after adminstration of WSC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median number of days of benefit	probability distribution of the difference in median number of days of benefit attributable to the intervention determined from the posterior distribution of state occupancy probabilities.	30 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily Clinical Status	longitudinal, ordinal state transition analysis of a patient's clinical status on any day within a 30-day window	30 day
Health Care Quality of Life (HCQOL)	HCQOL as assessed by PROMIS-29: Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) has a physical function scale ranging from 30-56 with higher scores representing better physical function. Anxiety, depression, fatigue, sleep disturbance, social function, pain interference have scales ranging from a low of 30-40 and a high of 60-80 with higher scores representing worse outcomes. Pain intensity is measured on a scale of 0 to 10 with 10 representing more pain.	30 Day

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Investigators: Principal Investigator: Edward H Livingston, MD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Estimated): August 15, 2025
• Primary Completion (Estimated): August 15, 2030
• Study Completion (Estimated): August 15, 2030

Study Registration Dates

• First Submitted: July 25, 2025
• First Submitted That Met QC Criteria: July 25, 2025
• First Posted (Actual): August 1, 2025

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: radiology; water soluble contrast
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Obstruction
• Other Study ID Numbers: 21-6143

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study will be of patients who are potentially identifiable. Data will not be publically available to protect their identities.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No