Capsule Endoscopy in Iron Deficiency Anaemia (WCE-IDA)

January 12, 2024 updated by: Vastra Gotaland Region

Diagnostic Yield of Video Capsule Endoscopy for Iron Deficiency Anaemia

This project aim to investigate whether wireless capsule endoscopy(WCE) has a similar diagnostic yield as conventional endoscopy in detecting the cause of iron deficiency anemia (IDA)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

IDA is common and 90-95% of cases are caused by bleeding from ulcers, tumours or vascular malformations in the oesophagus, stomach, duodenum, small intestine or the large bowel.Bleeding from more than one localisation is common.

International guidelines recommend bidirectional endoscopy(gastro- and colonoscopy) to detect and treat the source of bleeding.

Our hypothesis is that WCE is non-inferior to the combination of gastroscopy and colonoscopy in locating GI-bleeding and that complete examinations will be achieved in ≥90% of the examinations.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
      • Gothenburg, Sweden
        • Sahlgrenska University Hospital
        • Contact:
          • Thomas de Lange, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Persons with Iron Deficiency Anaemia referred for endoscopic diagnostic work-up

Description

Inclusion Criteria:

  • Referred to flexible endoscopy for a verified Iron Deficiency Anaemia

Exclusion Criteria:

  • Unwillingness to participate
  • Not able to provide informed consent
  • Not understanding the instructions
  • Severe cardio-vascular disease New York Heart Association III-IV
  • Symptoms of bowel obstruction/previous bowel obstruction
  • Bowel surgery except for end to end anastomosis in the colon
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Iron deficiency anaemia
Persons 18-85 years with Iron deficiency anaemia referred for gastroscopy and colonoscopy
Procedure: Endoscopy
Patients will be examined with gastroscopy, colonoscopy and WCE and the diagnostic yield of combined gastroscopy/colonoscopy will be compared to WCE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic yield
Time Frame: 90 minutes
Mucosal lesions detected
90 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Small bowel lesions
Time Frame: 90 minutes
Number of lesions detected in the small bowel
90 minutes
Complete examination
Time Frame: 90 minutes
Proportion of complete examinations
90 minutes
Bowel preparation
Time Frame: 90 minute
Proportion of satisfactory bowel preparation
90 minute
Adequate examinations
Time Frame: 90 minutes
Proportion of adequate examinations defined as both satisfactory bowel preparation and complete examination
90 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vastra Gotaland Region

Investigators

  • Principal Investigator: Thomas de Lange, PhD, Sahlgrenska University Hospital, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

January 12, 2024

First Submitted That Met QC Criteria

January 12, 2024

First Posted (Actual)

January 23, 2024

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 12, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 281233

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Iron Deficiency Anemia

Clinical Trials on Endoscopy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe