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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial uses intestinal ultrasound, a simple imaging test, to study pouchitis in individuals with a surgical pouch after ulcerative colitis surgery. The goal is to determine if ultrasound can effectively track and predict treatment response for this condition. A trained technician will image participants' pouches, and a specialist will review the results. This trial suits adults diagnosed with ulcerative colitis who have undergone surgery to create an ileal pouch. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance future treatment monitoring.

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 prior data suggests that intestinal ultrasound is safe for evaluating pouchitis?

Research shows that intestinal ultrasound (IUS) safely and easily detects inflammation in conditions like inflammatory bowel disease (IBD). Studies indicate that IUS is comfortable for patients and requires no special preparation, making it gentle on the body. Participants using IUS for IBD have not reported major side effects, suggesting it reliably monitors conditions like pouchitis without causing harm. For those considering a clinical trial involving IUS, current evidence supports its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using intestinal ultrasound for pouchitis because it offers a non-invasive way to assess inflammation. Unlike traditional methods, which often require endoscopic procedures that can be uncomfortable and invasive, ultrasounds are simpler and more patient-friendly. This technique allows for real-time imaging of the intestines without the need for sedation or radiation exposure, making it a safer option for ongoing monitoring of the condition. Plus, it could lead to quicker and easier assessments, helping doctors make more informed treatment decisions.

What evidence suggests that intestinal ultrasound is effective for assessing pouchitis?

Research shows that intestinal ultrasound (IUS) effectively checks inflammatory bowel diseases like pouchitis. It is accurate, non-invasive, and easy to use. One study found that IUS correctly identifies active disease 67% of the time and confirms pouchitis 97% of the time. This makes it quite reliable in confirming cases of pouchitis. Although image quality can vary based on the patient's size, studies indicate this does not affect accuracy. Overall, IUS offers a promising way to assess disease activity in pouchitis. Participants in this trial will undergo transabdominal and transperineal ultrasounds of the pouch, performed by an experienced sonographer and interpreted by a board-certified radiologist specializing in IUS. ^{4 5 6 7 8}

Who Is on the Research Team?

Darrell Pardi, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11025373/

Clinical Application of Intestinal Ultrasound in Inflammatory ... Intestinal ultrasound (IUS) is a non-invasive, accurate, and well-tolerated tool that provides real-time assessment of inflammatory bowel disease (IBD) ...

2. withpower.com withpower.com/trial/intestinal-ultrasound-for-pouchitis-4f033

Intestinal Ultrasound for Pouchitis · Info for Participants Intestinal ultrasound (IUS) demonstrated moderate sensitivity (67%) and high specificity (97%) for detecting endoscopically active disease in inflammatory bowel ...

3. cghjournal.org cghjournal.org/article/S1542-3565(24)00454-3/fulltext

AGA Clinical Practice Update on the Role of Intestinal ... Although IUS image quality may be limited in obese patients, a recent study showed no significant difference in IUS findings by weight for ...

4. trial.medpath.com trial.medpath.com/clinical-trial/cfc107e1427c53b1/nct06316999-utility-intestinal-ultrasound-diagnostic-tool-pouchitis-outcomes-ileal-pouch-anal

Intestinal Ultrasound for the Evaluation of Pouchitis and Other ... 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, ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1471489225000724

Shaping Surgical Decisions in IBD — Unveiling the Power ... In this setting, intestinal ultrasound (IUS) has emerged as a practical, non-invasive, cost-effective, and radiation-free imaging modality that ...

6. mayo.edu mayo.edu/research/clinical-trials/cls-20567313

Evaluating Pouchitis and Other Outcomes After Ileal Pouch ... About this study. The purpose of this study is to establish normal sonographic parameters in patients with an ileal pouch-anal anastomosis ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1521691825000848

A comprehensive guide to intestinal ultrasound in ... Ulcerative colitis (UC) is traditionally considered a mucosal disease, with endoscopy as the gold standard for diagnosis and monitoring.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9275009/

Intestinal Ultrasound in Inflammatory Bowel Disease IUS is a widely available imaging modality associated with low costs, an excellent safety profile, and lack of preparation [4]. It is increasingly recognised as ...