Capsule Endoscopy as an Alternative to Colonoscopy

Not Applicable

Recruiting

• Conditions: Colonic Disease
• Interventions: Device: Pillcam Crohn's Capsule Endoscopy

• Registration Number: NCT06031051
• Lead Sponsor: Hospital Clinic of Barcelona

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

Study Timeline

• Study Start: 2021-12-22
• Study First Submitted: 2023-03-01
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-01
• Last Update Submitted: 2023-09-01
• Study First Posted: 2023-09-11
• Last Update Posted: 2023-09-11
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 704

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pillcam Crohn's Capsule Endoscopy and colonoscopy	Pillcam Crohn's Capsule Endoscopy	All patients will be submitted to a Pillcam Crohn's Capsule Endoscopy (Medtronic) previous their colonoscopy

Primary Outcome Measures

Name	Time	Method
percentage of patients who could avoid colonoscopy	6 months	To evaluate the percentage of patients who could avoid colonoscopy by performing a previous CE

Secondary Outcome Measures

Name	Time	Method
CE diagnostic yield and adenoma detection rate (ADR)	6 months	Number of adenoma detected by CE
To compare CE and CC findings	6 months	Compare findings between both techniques

Trial Locations

Locations (4)

Hospital Mutua de Terrassa; 🇪🇸 Terrassa, Spain

Hospital Sant Pau; 🇪🇸 Barcelona, Spain

Hospital clinic of barcelona; 🇪🇸 Barcelona, Spain

Hospital universitario de Santa Cruz de Tenerife; 🇪🇸 Santa Cruz De Tenerife, Canarias, Spain