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

January 27, 2023 updated by: Krisztina Gecse, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
      • Lüneburg, Germany, 21339
      • Oldenburg, Germany, 26123
        • Not yet recruiting
        • Hospital of Oldenburg
        • Contact:
        • Sub-Investigator:
          • Ulf Helwig, MD, PhD
  • Italy
    • Rozzano
      • Milano, Rozzano, Italy, 20089
        • Not yet recruiting
        • Instituto Clinico Humanitas IRCSS
        • Contact:
        • Sub-Investigator:
          • Mariangela Allocca, MD, PhD
  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1105AZ
        • Recruiting
        • Amsterdam UMC
        • Contact:
        • Principal Investigator:
          • Krisztina Gecse, MD, PhD
        • Sub-Investigator:
          • Maarten Pruijt, MD, PhD candidate
  • United Kingdom
      • London, United Kingdom
        • Not yet recruiting
        • Guy's and St. Thomas' Hospitals
        • Contact:
        • Sub-Investigator:
          • Peter Irving, MD, PhD
        • Sub-Investigator:
          • Andrea Centritto, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with established Crohn's disease going through ICR will be eligible for inclusion

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Adult patients with an established diagnosis of CD going through ileocecal resection
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Time Frame: 6 months
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
• 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
Time Frame: 6 months
6 months
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)
Time Frame: 6 months
6 months
to develop an IUS score for postoperative recurrence in Crohn's disease
Time Frame: 6 months
6 months
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
Time Frame: 12-36 months
12-36 months
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
Time Frame: 6 - 36 months
6 - 36 months
to assess if SWE during IUS at 3, 6 and 12 months is predictive of anastomotic stenosis upon follow-up
Time Frame: 3-12 months
3-12 months
to assess the feasibility of IUS in the postoperative settings for different types of anastomosis
Time Frame: 3-6 months
3-6 months
to assess the diagnostic accuracy of FCal at 3 and 6 months to predict and determine endoscopic disease recurrence, respectively
Time Frame: 3-6 months
3-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 10, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2023

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2023

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • W21_405 # 21.452

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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