Diagnostic Accuracy of Capsule Endoscopy in Small Bowel Crohn's Disease

NCT00588653 | Completed Phase 4

• 1 other identifier: 2018-03
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective study to compare in a blinded fashion four different diagnostic modalities to detect active small bowel Crohn's disease: a) colonoscopy with ileoscopy; b) small bowel follow through; c) capsule endoscopy; and d) computed tomography enterography.

Conditions

Crohn's Disease

Keywords

Crohn's disease; capsule endoscopy; computed tomography enterography; colonoscopy; small bowel follow-through

Outcome Measures

Primary Outcomes (1)

• Sensitivity, positive predictive value, and accuracy of capsule endoscopy, CT enterography, colonoscopy with ileoscopy, and small bowel follow through using a consensus clinical diagnosis of small bowel Crohn's disease as the reference standard.

Secondary Outcomes (1)

• Describe spectrum of right colon lesions visualized by capsule endoscopy in patients with Crohn's disease.

Study Arms (1)

1

ACTIVE COMPARATOR

All patients were to undergo all 4 diagnostic modalities, and each of these was compared to the consensus clinical diagnosis. Readers of each modality were blinded to the results of the other 3.

Device: Capsule endoscopy, CT enterography, colonoscopy, small bowel follow-through

Interventions

Capsule endoscopy, CT enterography, colonoscopy, small bowel follow-through DEVICE

Each patient undergoes each of the 4 diagnostic modalities, but the readers are blinded to results of the other 3.

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatient of either sex aged 18 to 70 years
• Patient has suspected or definite Crohn's disease
• Patient has read, understood, and signed a written informed consent form at visit 1.

You may not qualify if:

• Pregnancy
• Patients who are prisoners, institutionalized individuals, or vulnerable adults
• Patients immediately in need of abdominal surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, perforation, or intra-abdominal abscess
• Patients with known or suspected gastrointestinal obstruction due to significant stricture based upon the clinical symptoms (nausea, vomiting, abdominal distention, or abdominal pain) confirmed by pre-procedure evaluation. Pre-procedure evaluation includes CT enterography or small bowel follow through performed at Mayo or previously at an outside institution which demonstrates mechanical obstruction (mechanical obstruction defined as small bowel narrowing with pre-stenotic dilatation); additionally, a high-grade stenotic ileocecal valve or ileocolonic anastomosis found by colonoscopy.
• Patients with history of abdominal radiation
• Patients with known or suspected oropharyngeal or esophageal dysphagia (unless recent EGD shows no evidence of mechanical obstruction of the esophagus, in cases of esophageal dysphagia)
• Patients with pacemakers or other implantable electromedical devices
• Patients with highly suspected or documented gastroparesis
• Patients who have used NSAIDs within the previous 2 weeks
• Patients with an anticipated need for an MRI scan within two weeks after M2A capsule ingestion (for patients who require a clinically indicated MRI, the MRI should be performed prior to administration of the M2A capsule)
• Patients with a creatinine ≥ 2.0.
• Patients with documented reaction to iodinated contrast material.
• Patients with an ileostomy or colostomy
• Patients with documented reaction to metoclopramide.
• Patients with a hemoglobin less than 7.5 g/dl. (Patients with Crohn's disease are often chronically anemic, and a hemoglobin of 7.5 g/dl or greater would allow these patients to safely participate in the study.)

Sponsors & Collaborators

• Mayo Clinic: lead
• Medtronic - MITG: collaborator

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Endoscopy; Colonoscopy

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Digestive System Surgical Procedures

Study Officials

• Edward V Loftus, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 8, 2008
• Study Start: January 1, 2004
• Primary Completion: August 1, 2004
• Study Completion: August 1, 2004
• Last Updated: January 8, 2008

Record last verified: 2007-12

Locations

US (1)