Capsule Endoscopy in Iron Deficiency Anaemia

Not yet recruiting

• Conditions: Iron Deficiency Anemia; Bowel Cancer
• Interventions: Procedure: Endoscopy

• Registration Number: NCT06219395
• Lead Sponsor: Vastra Gotaland Region

Brief Summary

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)

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 Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-12
• Study First Submitted QC: 2024-01-12
• Last Update Submitted: 2024-01-12
• Study First Posted: 2024-01-23
• Last Update Posted: 2024-01-23
• Study Start: 2024-03-01
• Primary Completion: 2025-02-28
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Referred to flexible endoscopy for a verified Iron Deficiency Anaemia

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Iron deficiency anaemia	Endoscopy	Persons 18-85 years with Iron deficiency anaemia referred for gastroscopy and colonoscopy

Primary Outcome Measures

Name	Time	Method
Diagnostic yield	90 minutes	Mucosal lesions detected

Secondary Outcome Measures

Name	Time	Method
Small bowel lesions	90 minutes	Number of lesions detected in the small bowel
Adequate examinations	90 minutes	Proportion of adequate examinations defined as both satisfactory bowel preparation and complete examination
Complete examination	90 minutes	Proportion of complete examinations
Bowel preparation	90 minute	Proportion of satisfactory bowel preparation

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden