Using capsule endoscopy instead of colonoscopy for colonic disease

Capsule Endoscopy as an Alternative to Colonoscopy. Could the Number of Colonoscopies be Reduced?

This study is testing if using a small camera capsule instead of a regular colonoscopy can help figure out which patients really need the colonoscopy, making the process easier and more efficient for everyone.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 704 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hospital Clinic of Barcelona (other)
• Locations: 4 sites (Santa Cruz De Tenerife, Canarias and 3 other locations)
• Trial ID: NCT06031051 on ClinicalTrials.gov

What this trial studies

This prospective, multicenter interventional study evaluates the effectiveness of capsule endoscopy (CE) as an alternative to traditional colonoscopy in patients scheduled for non-urgent colonoscopy. Patients will undergo CE to identify those who may not need a colonoscopy, thereby reducing unnecessary procedures and prioritizing patients who require endoscopic intervention. If CE results are negative, patients will proceed with their scheduled colonoscopy; if positive, a colonoscopy will be performed within 30 days. The study aims to improve patient management and optimize endoscopy resources.

Who should consider this trial

Good fit: Ideal candidates include patients with iron deficiency anemia, rectal bleeding, chronic gastrointestinal symptoms, or suspected colorectal cancer who are scheduled for a non-urgent colonoscopy.

Not a fit: Patients with complicated acute diverticulitis, positive FIT results, or contraindications to capsule endoscopy will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could reduce the number of unnecessary colonoscopies and improve patient prioritization for endoscopic procedures.

How similar studies have performed: Other studies have shown promise in using capsule endoscopy for similar purposes, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Iron deficiency anaemia with or without a colonoscopy performed within the last 5 years

  * Rectal bleeding/haematochezia in patients \>50 years who have undergone a colonoscopy \<5 years ago or \<50 years with no risk factors for CRC
  * Chronic constipation/abdominal distension/abdominal pain/diarrhea
  * Suspected CRC due to clinical criteria (NICE guidelines 2015, updated in 2017) with no iFOBT performed
  * Recent change in bowel habits
  * Follow-ups: post-polypectomy syndrome, family history of CRC, hereditary syndromes, CRC surgery, Inflammatory Bowel Disease

Exclusion Criteria:

* Study following an episode of complicated acute diverticulitis or with an uncertain diagnosis of acute diverticulitis
* Evaluation following fragmented resection (recurrence ruled out)
* Patients with a positive FIT
* Pregnancy or breast-feeding
* Any contraindication to Crohn's Capsule endoscopy such as known or suspected gastrointestinal obstruction, strictures or fistulas, a previous altered Patency capsule, dysphagia or other swallowing disorders and cardiac pacemakers or other implanted electromedical devices.
* Allergy or known contraindication to the medications and preparations agents used in the procedure.

Where this trial is running

Santa Cruz De Tenerife, Canarias and 3 other locations

• Hospital universitario de Santa Cruz de Tenerife — Santa Cruz De Tenerife, Canarias, Spain (RECRUITING)
• Hospital clinic of barcelona — Barcelona, Spain (RECRUITING)
• Hospital Sant Pau — Barcelona, Spain (RECRUITING)
• Hospital Mutua de Terrassa — Terrassa, Spain (RECRUITING)

Study contacts

• Principal investigator: BEGOÑA GONZALEZ SUAREZ, MD PhD — Hospital Clinic of Barcelona
• Study coordinator: BEGOÑA GONZALEZ SUAREZ, MD, PhD

Conditions: Colonic Disease