Intestinal Ultrasound for Pouchitis

Overseen By Patricia Kammer, CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Pediatric, Indeterminate colitis, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

109 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Intestinal Ultrasound for Pouchitis?

Research shows that intestinal ultrasound (IUS) is effective in assessing inflammation and disease activity in conditions like inflammatory bowel disease (IBD) and ulcerative colitis (UC). It is noninvasive and helps in monitoring treatment response, which suggests it could be useful for managing pouchitis as well. ^{1 2 3 4 5}

Is intestinal ultrasound safe for humans?

Intestinal ultrasound (IUS) is considered a safe, non-invasive method for assessing inflammation in conditions like inflammatory bowel disease (IBD) and ulcerative colitis (UC). It is comparable in accuracy to other diagnostic tools like endoscopy and magnetic resonance enterography, without the need for invasive procedures. ^{1 2 3 6 7}

How is intestinal ultrasound different from other treatments for pouchitis?

Intestinal ultrasound is unique because it is a non-invasive imaging technique used to assess inflammation in the intestines, unlike traditional treatments that may involve medication or surgery. It provides real-time information about disease activity without the need for invasive procedures. ^{2 3 5 6 8}

What is the purpose of this trial?

Intestinal ultrasound (IUS) has been studied in the evaluation of inflammatory bowel disease (IBD) and is increasingly used as a non-invasive, easy to use, cost-effective tool for point-of-care to assess disease activity and more recently to predict response to treatment. However, there is a paucity of data on the use of IUS specifically for ulcerative colitis (UC) patients with an ileal pouch-anal anastomosis (IPAA).

Research Team

Darrell Pardi, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for individuals with ulcerative colitis who have undergone a surgery called ileal pouch-anal anastomosis. It's designed to see if intestinal ultrasound can help evaluate a condition known as pouchitis and other outcomes after this procedure.

Inclusion Criteria

I have completed all stages of my IPAA surgery.

I have been diagnosed with ulcerative colitis.

Exclusion Criteria

I am under 18 years old.

I had surgery for FAP.

Pregnant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Evaluation

Transabdominal and transperineal ultrasounds of the pouch are performed and interpreted by specialists

1 year

Regular visits for ultrasound assessments

Follow-up

Participants are monitored for safety and effectiveness after diagnostic evaluations

4 weeks

Treatment Details

Interventions

• Intestinal Ultrasound

Trial Overview The study is testing the use of intestinal ultrasound (IUS) as a non-invasive tool to assess disease activity in patients with UC who have had IPAA surgery, aiming to understand its effectiveness in evaluating pouchitis.

Participant Groups

Group I: Patients with Pouchitis Experimental Treatment 1 Intervention

Transabdominal and transperineal ultrasounds of the pouch will be performed by an experienced sonographer for each patient and interpreted by a board-certified radiologist specializing in IUS.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

Point-of-care intestinal ultrasound (IUS) significantly impacts disease management in inflammatory bowel disease (IBD) patients, with 60% of cases leading to changes in medication and a strong correlation with additional imaging methods like endoscopy and MRI.

IUS can effectively detect inflammation in both symptomatic and asymptomatic Crohn's disease patients, suggesting its utility in monitoring treatment response and potentially reducing the need for more invasive procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Point-of-care Intestinal Ultrasound in IBD Patients: Disease Management and Diagnostic Yield in a Real-world Cohort and Proposal of a Point-of-care Algorithm. Bots, S., De Voogd, F., De Jong, M., et al.[2022]

Intestinal ultrasound (IUS) demonstrated moderate sensitivity (67%) and high specificity (97%) for detecting endoscopically active disease in inflammatory bowel disease (IBD) patients, based on a study of 51 individuals.

IUS was particularly effective in assessing the transverse colon, achieving 100% sensitivity and 95% specificity for detecting active disease, suggesting it can be a valuable tool in managing IBD alongside traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of intestinal ultrasound for disease activity assessment in patients with inflammatory bowel disease: A cross-sectional study at a tertiary centre in Malaysia. Lim, KY., Raja Ali, RA., Wong, Z., et al.[2023]

In a study of 60 patients with ulcerative colitis, an intestinal ultrasound (IUS) index was developed that effectively correlates with endoscopic disease activity, demonstrating strong reliability and validity.

Key ultrasound parameters, such as bowel wall thickness and the presence of color Doppler signals, were identified as effective indicators of disease severity, with specific cut-off values providing high sensitivity and specificity for different levels of disease activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intestinal Ultrasound to Assess Disease Activity in Ulcerative Colitis: Development of a novel UC-Ultrasound Index. Bots, S., Nylund, K., Löwenberg, M., et al.[2021]

Intestinal ultrasound (IUS) is a highly accurate, noninvasive method for assessing treatment response in patients with moderate to severe ulcerative colitis (UC), correlating well with endoscopic and histological outcomes.

In this study of 30 patients starting tofacitinib treatment, bowel wall thickness (BWT) was identified as the key parameter for evaluating treatment response, with specific cutoff values indicating endoscopic remission and improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intestinal Ultrasound Is Accurate to Determine Endoscopic Response and Remission in Patients With Moderate to Severe Ulcerative Colitis: A Longitudinal Prospective Cohort Study. de Voogd, F., van Wassenaer, EA., Mookhoek, A., et al.[2023]

In a study of 33 children suspected of having inflammatory bowel disease (IBD), increased bowel wall thickness (BWT) measured by intestinal ultrasound (IUS) was significantly associated with higher disease severity as assessed by endoscopy.

The study found that a BWT cutoff value of 1.9 mm had a sensitivity of 64% and specificity of 76% for detecting inflamed bowel, suggesting that the optimal BWT threshold for pediatric patients may be lower than that established for adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bedside Intestinal Ultrasound Predicts Disease Severity and the Disease Distribution of Pediatric Patients With Inflammatory Bowel Disease: A Pilot Cross-sectional Study. Chavannes, M., Hart, L., Hayati Rezvan, P., et al.[2023]

An international consensus was reached among 54 experts from 17 countries on the essential knowledge and skills required for newly certified practitioners of intestinal ultrasound (IUS), resulting in 41 agreed-upon competency statements.

This consensus provides a foundational framework for developing training programs and evaluating the competencies of IUS trainees, enhancing the quality and consistency of IUS practice in monitoring inflammatory bowel diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The knowledge and skills needed to perform intestinal ultrasound for inflammatory bowel diseases-an international Delphi consensus survey. Madsen, GR., Wilkens, R., Boysen, T., et al.[2022]

Intestinal ultrasound (IUS) is a noninvasive and reliable tool for assessing bowel inflammation, showing accuracy comparable to more invasive methods like endoscopy and magnetic resonance enterography.

Despite its effectiveness, IUS has faced challenges in being adopted in the United States for inflammatory bowel disease (IBD) management, including limited educational resources and unclear reimbursement processes, but new training pathways and billing practices are being developed to facilitate its integration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Arrival of Intestinal Ultrasound for Inflammatory Bowel Disease Care in the United States. Cleveland, NK., Picker, EA., Dolinger, MT., et al.[2023]

Intestinal ultrasound (IUS) is a non-invasive and effective tool for pediatric gastroenterologists to detect and monitor inflammatory bowel disease (IBD) in children, allowing visualization of the colon without the need for bowel preparation or sedation.

IUS has shown high accuracy compared to endoscopy for assessing IBD activity and may serve as a reliable biomarker for treatment response, making it a valuable point-of-care option for ongoing management of children with IBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Point-of-Care Intestinal Ultrasound in Pediatric Inflammatory Bowel Disease. Dolinger, MT., Kellar, A.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Point-of-care Intestinal Ultrasound in IBD Patients: Disease Management and Diagnostic Yield in a Real-world Cohort and Proposal of a Point-of-care Algorithm. [2022]

2. India pubmed.ncbi.nlm.nih.gov

Evaluation of intestinal ultrasound for disease activity assessment in patients with inflammatory bowel disease: A cross-sectional study at a tertiary centre in Malaysia. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Intestinal Ultrasound to Assess Disease Activity in Ulcerative Colitis: Development of a novel UC-Ultrasound Index. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Intestinal Ultrasound Is Accurate to Determine Endoscopic Response and Remission in Patients With Moderate to Severe Ulcerative Colitis: A Longitudinal Prospective Cohort Study. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Bedside Intestinal Ultrasound Predicts Disease Severity and the Disease Distribution of Pediatric Patients With Inflammatory Bowel Disease: A Pilot Cross-sectional Study. [2023]

6. England pubmed.ncbi.nlm.nih.gov

The knowledge and skills needed to perform intestinal ultrasound for inflammatory bowel diseases-an international Delphi consensus survey. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The Arrival of Intestinal Ultrasound for Inflammatory Bowel Disease Care in the United States. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Point-of-Care Intestinal Ultrasound in Pediatric Inflammatory Bowel Disease. [2023]