Capsule Endoscopy in Iron Deficiency Anaemia

NCT ID: NCT06219395

Last Updated: 2024-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-09-30

Brief Summary

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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

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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.

Conditions

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Iron Deficiency Anemia Bowel Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Iron deficiency anaemia

Persons 18-85 years with Iron deficiency anaemia referred for gastroscopy and colonoscopy

Endoscopy

Intervention Type PROCEDURE

Patients will be examined with gastroscopy, colonoscopy and WCE and the diagnostic yield of combined gastroscopy/colonoscopy will be compared to WCE

Interventions

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Endoscopy

Patients will be examined with gastroscopy, colonoscopy and WCE and the diagnostic yield of combined gastroscopy/colonoscopy will be compared to WCE

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vastra Gotaland Region

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas de Lange, PhD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Locations

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Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status

Countries

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Sweden

Central Contacts

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Thomas de Lange, PhD

Role: CONTACT

+46702794054

Nikolaos Papachrysos, PhD

Role: CONTACT

Facility Contacts

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Thomas de Lange, PhD

Role: primary

Other Identifiers

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281233

Identifier Type: -

Identifier Source: org_study_id

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