Clinical trial NCT06031051: Capsule Endoscopy as an Alternative to Colonoscopy
Official title: Capsule Endoscopy as an Alternative to Colonoscopy. Could the Number of Colonoscopies be Reduced?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colonic Disease
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2023-09-11
Enrollment: 704
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective, multicenter, interventional study assessing CE, in patients already scheduled for colonoscopy at tertiary referral hospitals, as a technique to reduce the number of unnecessary colonoscopies and identify patients to prioritize in endoscopy waiting lists.

Detailed description: Study design Enrolled patients already scheduled for non-urgent colonoscopy according to local practice will be offered to undergo an early CE; in case of negative proof they will perform colonoscopy as already planned (scheduled colonoscopy); in patients with positive findings, requiring endoscopic treatment or intervention, colonoscopy will be performed within 30 days from CE (early colonoscopy).

Study population Patients who received the indication for colonoscopy as per clinical practice and subsequently identified as non-urgent procedures, according to locally established prioritization criteria

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.

Primary outcomes:
measure: percentage of patients who could avoid colonoscopy
timeFrame: 6 months
Secondary outcomes:
measure: CE diagnostic yield and adenoma detection rate (ADR)
timeFrame: 6 months
measure: To compare CE and CC findings
timeFrame: 6 months
Other outcomes:
Locations:
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital universitario de Santa Cruz de Tenerife
state: Canarias
city: Barcelona
country: Spain
facility: Hospital clinic of barcelona
city: Barcelona
country: Spain
facility: Hospital Sant Pau
city: Terrassa
country: Spain
facility: Hospital Mutua de Terrassa
Study officials:
affiliation: Hospital Clinic of Barcelona
name: BEGOÑA GONZALEZ SUAREZ, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: