Prediction and Close Monitoring of Postoperative Recurrence by Intestinal Ultrasound After Ileocecal Resection in Crohn's Disease Patients

Crohn Disease Clinical Trial

— INSIGHT  

Official title:

Prediction and Close Monitoring of Postoperative Recurrence by Using Intestinal Ultrasonography After Ileocecal Resection in Crohn's Disease Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05713409
• Other study ID #: W21_405 # 21.452
• Status: Recruiting
• Start date: February 10, 2022
• Est. completion date: May 1, 2025

Study information

• Verified date: January 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Maarten Pruijt, MD, PhD candidate
• Phone: +31650091289
• Email: m.j.pruijt[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Crohn's disease (CD) is an inflammatory bowel disease causing chronic transmural inflammation followed by intestinal complications including strictures and penetrating lesions such as fistulas and abscesses. 30-50% of the CD patients will require surgery during the course of their disease. Unfortunately, resection is not curative and endoscopically recurrent lesions (i.e. endoscopic recurrence) are observed in 65-90% of patients within 12 months, and in 80-100% within 3 years after the operation. Eventually 15-20% of patients will require new surgery within 5 years. Close monitoring for postoperative recurrence is therefore needed to perform early intervention and prevent clinical recurrence and need for re-surgery. Endoscopy is the gold standard to assess postoperative disease recurrence however it's limited by its invasiveness. Cross sectional imaging is known for accurate detection of postoperative recurrence. Intestinal ultrasound (IUS) of the colon and (neo)terminal ileum correlates well with CT, MRE and colonoscopy findings in the postoperative setting. IUS is non-invasive, cheap, readily available and may show early, signs of disease recurrence. Therefore it could be a useful tool to predict endoscopic recurrence at 6 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• confirmed diagnosis of Crohn's disease

• undergoing ICR (or re-resection)

• =16 years of age

Exclusion Criteria:

• <16 years of age

• Inability to give informed consent

• Ongoing gastroenteritis

• Deviating stoma

• (Sub)total colectomy

• Obesity (BMI >35 kg/m²)

• Insufficient visualization of the anastomosis AND the neo-terminal ileum at baseline IUS

Related Conditions & MeSH terms

• Crohn Disease
• Recurrence

Intervention

Diagnostic Test:
• Intestinal ultrasound
As part of the routine care, patients will undergo ileocolonoscopy at 6 months, IUS will be performed 3, 6, 12, 18, 24, 30 and 36 months (using B-mode and CDS) and at 3 and 6 months elastography will be performed on the neo-terminal ileum. Biomarkers (CRP and fecal calprotectine) will be measured according to routine care.

Locations

Country	Name	City	State
Germany	Klinikum Lüneburg	Lüneburg
Germany	Hospital of Oldenburg	Oldenburg
Italy	Instituto Clinico Humanitas IRCSS	Milano	Rozzano
Netherlands	Amsterdam UMC	Amsterdam	Noord-Holland
United Kingdom	Guy's and St. Thomas' Hospitals	London

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Countries where clinical trial is conducted

Germany,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary aim of the study is to investigate if IUS (as measured by B-mode and CDS) in combination with faecal calprotectin at 3 months after ICR is an early surrogate marker of endoscopic disease recurrence (as defined by a RS = i2) at 6 months		6 months
Secondary	• To assess if IUS (as measured by B-mode, CDS and SWE) alone at 3 months after ICR is an early surrogate marker of endoscopic disease recurrence (as defined by a RS = i2) at 6 months		6 months
Secondary	to assess if IUS (as measured by B-mode, CDS and SWE) alone or in combination with faecal calprotectin at 6 months after ICR is accurate in detecting endoscopic recurrence at 6 months (as defined by a RS score = i2 and by the SES-CD?3)		6 months
Secondary	to develop an IUS score for postoperative recurrence in Crohn's disease		6 months
Secondary	to assess if IUS (as measured by B-mode, CDS and SWE) alone or in combination with faecal calprotectin at 12 months after ICR is a surrogate marker of endoscopic disease recurrence (RS= 2) at 18 months and/or clinical outcomes at 18, 24, 30 and 36 months		12-36 months
Secondary	to compare IUS (as measured by B-mode, CDS and SWE; alone or in combination with faecal calprotectin) and the RS upon endoscopy at 6 months after ICR for their prognostic role on clinical outcomes upon 3 years of follow-up		6 - 36 months
Secondary	to assess if SWE during IUS at 3, 6 and 12 months is predictive of anastomotic stenosis upon follow-up		3-12 months
Secondary	to assess the feasibility of IUS in the postoperative settings for different types of anastomosis		3-6 months
Secondary	to assess the diagnostic accuracy of FCal at 3 and 6 months to predict and determine endoscopic disease recurrence, respectively		3-6 months