Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease (ANDI-3)

Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease - a Prospective Comparison of Pan-Enteric Capsule Endoscopy Versus Ileocolonoscopy Plus MR Enterography or Small-Bowel Capsule Endoscopy

The goal of this clinical trial is to learn whether a camera pill examination of the whole bowel can be used to diagnose Crohn's disease instead of colonoscopy and a small bowel examination (either MRI or camera pill) in patients aged 18-40 years suspected of having Crohn's disease.

The main question it aims to answer is:

How many patients examined with a camera pill examination of the whole bowel will have a complete examination of the whole bowel and have a diagnosis made without need for any more examinations?

Researchers will compare with patients examined with colonoscopy and a small bowel examination.

Participants will:

• Be examined with either a camera pill examination of the whole bowel, or a colonoscopy and a small bowel examination
• Have their electronic medical records checked to see if a diagnosis has been made
• Have an interview every three months if diagnosed with an inflammatory bowel disease or after a year if no disease was found

Study Overview

• Status: Recruiting
• Conditions: Crohn's Disease
• Intervention / Treatment: Diagnostic test: Panenteric capsule endoscopy; Diagnostic test: Ileocolonoscopy; Diagnostic test: MRI enterography; Diagnostic test: Small bowel capsule endoscopy

• Study Type: Interventional
• Enrollment (Estimated): 165
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Frederik D Thrane, MD; Phone Number: 0045 79183140; Email: Frederik.Drejer.Thrane2@rsyd.dk
• Study Contact Backup: Name: Michael D Jensen, MD, PhD; Phone Number: 0045 79183140; Email: Michael.Dam.Jensen@rsyd.dk

Study Locations

• Denmark
  • Esbjerg, Denmark, 6700
    • Recruiting
    • Esbjerg Hospital - University Hospital of Southern Denmark
    • Contact: Michael D Jensen, MD, PhD; Phone Number: 0045 79183146; Email: Michael.Dam.Jensen@rsyd.dk
  • Odense C, Denmark, 5000
    • Recruiting
    • Odense University Hospital
    • Contact: Frederik D Thrane, MD; Phone Number: 0045 65412755; Email: Frederik.Drejer.Thrane2@rsyd.dk
  • Svendborg, Denmark, 5700
    • Not yet recruiting
    • Odense University Hospital - Svendborg Hospital
    • Contact: Claus Aalykke, MD, PhD; Phone Number: 0045 63312906; Email: Claus.Aalykke@rsyd.dk
  • Vejle, Denmark, 7100
    • Recruiting
    • Lillebaelt Hospital Vejle - University Hospital of Southern Denmark
    • Contact: Maiken T Jørgensen, MD, PhD; Phone Number: 0045 79406345; Email: Maiken.T.Joergensen@rsyd.dk
• Sweden
  • Malmö, Sweden, 205 02
    • Not yet recruiting
    • Skane University Hospital
    • Contact: Gabriele W Johansson, MD, PhD; Phone Number: 0046 40338622; Email: Gabriele.WurmJohansson@skane.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Clinical suspicion of CD*
• Age 18-40 years

• Signed informed consent

  *A clinical suspicion of CD is based on the following definition:

• Diarrhea and/or abdominal pain for more than 1 month (or repeated episodes of diarrhea and/or abdominal pain) and either

  • fecal calprotectin ≥ 200 mg/kg or
  • fecal calprotectin ≥ 50 mg/kg plus one or more of the following findings:
• C-reactive protein (CRP) > 5 mg/L
• Thrombocytosis (> 400 x 109/L)
• Anemia (hemoglobin < 7.0 mmol/L for women and < 8.0 mmol/L for men or a decrease > 0.5 mmol/L compared to the usual level)
• Prolonged fever (> 37.5 ◦C for more than 2 weeks)
• Weight loss (≥ 3 kg or ≥ 5% compared to the normal body weight)
• Perianal abscess / fistula
• Family history of inflammatory bowel disease.

Exclusion Criteria:

• Previous intestinal resection
• Positive serologic markers for celiac disease
• Positive stool polymerase chain reaction for pathogenic bacteria
• Positive stool polymerase chain reaction for intestinal parasites
• Suspected or established acute bowel obstruction (ileus)
• Intake of NSAIDs or acetylsalicylic acid ≤ 4 weeks before inclusion, except low-dose, prophylactic acetylsalicylic acid (≤ 150 mg per day)
• Intake of opioid or opioid-like medications ≤ 1 week before inclusion
• Pregnancy or lactation
• Inability to comply with protocol requirements, e.g. for reasons including alcohol or recreational drug abuse
• Known gastrointestinal disorder other than functional gastrointestinal disorders
• Renal failure defined by a plasma-creatinine above the normal reference range

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Minimally invasive diagnostic algorithm	Diagnostic test: Panenteric capsule endoscopy; Panenteric capsule endoscopy
Active Comparator: Traditional work-up; Colonoscopy and either MRI enterography or small bowel capsule endoscopy	Diagnostic test: Ileocolonoscopy; Endoscopic examination of the colon and terminal ileum after bowel preparation.; Diagnostic test: MRI enterography; MRI of the small bowel; Diagnostic test: Small bowel capsule endoscopy; Capsule endoscopy of the small bowel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic completeness	Proportion of patients in each arm achieving a complete gastrointestinal assessment and an unambiguous diagnosis after completion of the initial diagnostic procedure(s) without need for supplementary examinations	Immediately after initial diagnostic procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of pan-enteric CE	Number of patients with suspected CD examined with pan-enteric CE and the number of ICs avoided	After completion of follow-up (12 months)
Additional examinations	Need for additional examinations in the two randomization arms	After completion of follow-up (12 months)
Safety	Number of severe adverse events	After completion of follow-up (12 months)
Time to diagnosis	Time from referral or first diagnostic procedure to final diagnosis and treatment	After completion of follow-up (12 months)
Disease classification and medical treatments	Disease classification and medical treatments in the two randomization arms	After completion of follow-up (12 months)
Patient satisfaction	Difference in Gastrointestinal Endoscopy Satisfaction Questionnaire (GESQ) score	Immediately after initial diagnostic procedure
Costs	Expenditure on diagnostic procedures, treatment and loss of productivity	After completion of follow-up (12 months)
Artificial intelligence	Diagnostic utility of AI algorithms in detection of gastrointestinal pathology using pan-enteric CE - sensitivity, specificity, severity, prediction and impact on clinical decision making	Immediately after initial diagnostic procedure

Collaborators and Investigators

• Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
• Collaborators: Odense University Hospital; Vejle Hospital; Skane University Hospital; Svendborg Hospital
• Investigators: Principal Investigator: Frederik D Thrane, MD, Esbjerg Hospital - University Hospital of Southern Denmark

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: February 26, 2025
• First Submitted That Met QC Criteria: March 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: inflammatory bowel disease; capsule endoscopy; panenteric capsule endoscopy; Crohn&#39;s disease
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 24/50881

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No