Health TrialsbyHealthPanel

Early Videocapsule Endoscopy for Upper Gastrointestinal Bleeding

ConditionSmall Bowel Bleeding
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity of Alberta

About this trial

The objective of this study is to determine whether early video capsule endoscopy (VCE) immediately after a negative gastroscopy in the setting of suspected upper gastrointestinal bleeding (UGIB) improves patient outcomes as compared to the standard approach which typically involves performing colonoscopy prior to small bowel investigations. We aim to examine the differences in diagnostic yield, total number of procedures, length of hospitalization, mortality rates, and healthcare cost between the two groups.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

The presence of melena/maroon stool on physical exam OR history of melena/maroon stool within 48 hours of emergency room presentation PLUS

Hemoglobin drop of ≥ 20 g/L from patient's baseline

Have capacity to consent

Disqualifiers

Inability to provide consent due to lack of capacity, language barrier or other reasons

Pregnant women

Prior history of small bowel surgery

Prior history of Crohn's disease

Trial design

Design model

Single group

Treatments tested in this trial

  • Videocapsule endoscopy

    Procedure/Surgery

    Endoscopic drop of videocapsule in duodenum after initial negative gastroscopy

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Early small bowel investigationExperimental treatment 1 intervention
Group B: ColonoscopyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Diagnostic yield

Diagnostic yield of videocapsule endoscopy after initial negative gastroscopy

Time frame
30 days
2

Diagnostic yield of colonoscopy after initial negative gastroscopy

Time frame
30 days

Secondary outcomes

1

Time from presentation to localization of bleeding source

Time frame
30 days
2

Recurrence of bleeding

Time frame
30 days
3

Length of stay in hospital

Time frame
30 days
4

Adverse events in both groups

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alberta

Lead sponsor

Source ClinicalTrials.gov
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