Clinical trial NCT05713409: Prediction and Close Monitoring of Postoperative Recurrence by Intestinal Ultrasound After Ileocecal Resection in Crohn's Disease Patients
Official title: Prediction and Close Monitoring of Postoperative Recurrence by Using Intestinal Ultrasonography After Ileocecal Resection in Crohn's Disease Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Crohn Disease
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 120
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with established Crohn's disease going through ICR will be eligible for inclusion

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 6 months
Secondary outcomes:
measure: • 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
timeFrame: 6 months
measure: 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)
timeFrame: 6 months
measure: to develop an IUS score for postoperative recurrence in Crohn's disease
timeFrame: 6 months
measure: 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
timeFrame: 12-36 months
measure: 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
timeFrame: 6 - 36 months
measure: to assess if SWE during IUS at 3, 6 and 12 months is predictive of anastomotic stenosis upon follow-up
timeFrame: 3-12 months
measure: to assess the feasibility of IUS in the postoperative settings for different types of anastomosis
timeFrame: 3-6 months
measure: to assess the diagnostic accuracy of FCal at 3 and 6 months to predict and determine endoscopic disease recurrence, respectively
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Lüneburg
country: Germany
facility: Klinikum Lüneburg
city: Oldenburg
country: Germany
facility: Hospital of Oldenburg
city: Milano
country: Italy
facility: Instituto Clinico Humanitas IRCSS
state: Rozzano
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
state: Noord-Holland
city: London
country: United Kingdom
facility: Guy's and St. Thomas' Hospitals
Study officials:
References: