Correlation of Cross Sectional Imaging and Small Intestinal Contrast Ultrasonography in Known Crohn's Disease

NCT06125678 | Completed DMC

• 1 other identifier: AIG/IEC-BH&R 49 / 06.2023-04
• Study Type: interventional
• Target: 407
• Locations: 1 country
• Sites: 1

Brief Summary

Small intestinal contrast ultrasound (SICUS) is a modality of intestinal ultrasound (IUS) which does not require any parenteral administration of contrast agent but requires ingestion of around 500 ml of polyethylene glycol (PEG). SICUS does not involve any radiation. Computed tomography enteroclysis (CTE) requires colonic cleansing using polyethylene glycol (PEG) followed by infusion of 1.5 litres of PEG via a nasal catheter to distend and properly visualise the small intestine. CTE although accurate for assessing response to therapy and transmural healing in small bowel CD is associated with radiation and adds to cost of management. Magnetic resonance enterography (MRE) using PEG followed by 2 liters of oral fluid with mannitol was administered to distend and properly visualize the small intestine. MRE although accurate for assessing response to therapy and transmural healing in small bowel CD is associated with radiation and adds to cost of management. On the other hand, SICUS is relatively non-invasive method of small bowel assessment although the accuracy has not been studied prospectively. An earlier retrospective study in which MRE/CTE and SICUS are done within 3 months of each other, SICUS had identified lesions and complications in patients with CD with high levels of sensitivity, specificity, and accuracy compared to CT-enteroclysis (3). These findings need prospective validation. The accuracy of SICUS may be suboptimal due to constant peristalsis in the small intestine. Hence the investigators planned this study to perform SICUS in patients with small bowel CD who otherwise require a MRE/CTE for disease monitoring on the same day before the procedure with the same PEG preparation. If SICUS findings are found to correlate with MRE/CTE findings intros study, SICUS have the potential to replace other modalities for monitoring of small bowel Crohn's disease (CD) and emerge as a cost-effective, easy alternative. The investigators also want to understand the drawbacks and limitations of SICUS in this scenario.

Conditions

Crohn Disease; Ultrasound Therapy; Complications; Computed Tomography; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Change in management decision after cross sectional imaging compared to ultrasound

  Percentage of patients in which cross sectional imaging changed the management decision

  Day 1

Secondary Outcomes (3)

• Correlation between bowel wall thickness in affected area in small intestine between small intestinal contrast ultasonography and cross sectional imaging

  Day 1

• Agreement for extent of involvement in affected area of small intestine between small intestinal contrast ultasound and cross sectional imaging

  Day 1

• Agreement for detecting complications between small intestinal contrast ultrasound and cross sectional imaging

  Day 1

Study Arms (1)

Small intestinal contrast enhanced ultrasound followed by cross sectional imaging

EXPERIMENTAL

Patients shall be undergoing small intestinal contrast enhanced ultrasound followed by cross sectional imaging

Diagnostic Test: Small intestinal contrast enhanced ultrasound followed by Computed tomography/Magnetic resonance enterography

Interventions

Small intestinal contrast enhanced ultrasound followed by Computed tomography/Magnetic resonance enterography DIAGNOSTIC_TEST

First small intestinal contrast enhanced ultrasound shall be done followed by CT enterography or MR enterography

Small intestinal contrast enhanced ultrasound followed by cross sectional imaging

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with known small bowel CD beyond reach of standard endoscopy who warrants monitoring of disease status either due to assessment of response to therapy/relapse/new unexplained symptoms, persistent disease activity, prior to switching therapy or deciding on surgical management.

You may not qualify if:

• Obese patients with poor ultrasound window
• pregnant/lactating mother
• Not willing for CT or enteroclysis examination
• Renal insufficiency precluding CT

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian Institute of Gastroenterology

Hyderabad, Telangana, 500082, India

Location

Related Publications (1)

• Pal P, Mateen MA, Pooja K, Marri UK, Reddy CR, Salman S, Piprikar R, Gupta R, Tandan M, Reddy DN. Correlation and Assessment of Small Bowel Lesions Using Cross-Sectional Imaging Techniques Compared With Small Intestinal Contrast Ultrasonography in Known Crohn's Disease (the CACTUS-CD Study): A Paired, Prospective, Confirmatory Study. Am J Gastroenterol. 2025 Sep 29. doi: 10.14309/ajg.0000000000003776. Online ahead of print.

  PMID: 41020653 DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Partha Pal, MD, DrNB

  Asian Institute of Gastroenterology and Asian Healthcare Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2023
• First Posted: November 9, 2023
• Study Start: July 20, 2023
• Primary Completion: February 25, 2025
• Study Completion: February 26, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)