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Use of PillCam ESO2 in Triaging Patients Present With Upper GIB

NCT02446678 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2017-04-25

No results posted yet for this study

Summary

Background

* Patients presented to hospital with coffee ground vomiting and black stool may not be actually having upper gastrointestinal bleeding (UGIB)
* Hospital admission can be avoided if serious UGIB can be excluded
* To date, the only useful tool to triage patient for hospital admission in UGIB is by using clinical score such as Rockall score or Blatchford score
* These scores are cumbersome and only exclude the most benign cases, but they are not useful in differentiating those who needs intervention
* In our pilot study, investigators found that capsule endoscopy can be used to identify patients with fresh blood and real coffee ground substance in the stomach and it is superior to nasogastric tube
* Most of UGI lesions leading to bleeding can be diagnosed by capsule endoscopy

Objectives The current study is designed

1. to validate capsule endoscopy is an effective method in identifying patients with UGIB
2. to study whether the capsule endoscopy can reduce requirement of hospital admission in patients with suspected UGIB
3. to study if capsule endoscopy can help to identify patients with UGIB that may require urgent (within 24 hours) endoscopy and intervention
4. to study the cost-effectiveness of capsule endoscopy being used as a triaging tool in the management of UGIB
5. to compare the effectiveness of capsule endoscopy against Blatchford score in identifying patients with UGIB that may require endoscopic intervention.

Conditions

  • Upper Gastrointestinal Bleeding

Interventions

DEVICE

PillCam ESO2

Capsule endoscopy

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Jessica Y.L. Ching, MPH · Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-04-30
Completion
2016-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02446678 on ClinicalTrials.gov