Completed

Urgent vs. Early Endoscopy in High Risk Patients With UGIB

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What is being tested

Urgent endoscopy

+ Early endoscopy

Other
Who is being recruted

Digestive System Diseases+4

+ Gastrointestinal Diseases

+ Hemorrhage

Over 18 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Placebo-Controlled
Interventional
Study Start: July 2012
See protocol details

Summary

Principal SponsorChinese University of Hong Kong
Last updated: February 1, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: July 28, 2012

Actual date on which the first participant was enrolled.

The GBS, being a pre-endoscopy score with clinical parameters, is more suitable for patient triage leading to urgent endoscopy and a higher level of care. A GBS of 0 has been shown to identify patients with upper gastrointestinal bleeding who may be managed safely as outpatients. The proportion of patients requiring endoscopic therapy increases with a higher score. A cut-off score that identifies "high-risk" patients who may benefit from urgent intervention however has not been determined. Guidelines from Societies around the world recommend early endoscopy within 24 hours of presentation for acute upper gastrointestinal bleeding (AUGIB). The guidelines also state that a proportion of patients need emergency "out-of-hours" endoscopy, without defining the "high-risk" group. A recent international consensus on the management of NVUGIB recommended early endoscopy within 24 hours for Non-Variceal Upper Gastro Intestinal Bleeding (NVUGIB), and noted no additional benefit associated with urgent endoscopy (<12 hours) vs. early endoscopy (>12 hours) in unselected patients with NVUGIB. However, there are only limited data on the role of urgent endoscopy in the "selected" subgroup of patients with high-risk NVUGIB.

Principal SponsorChinese University of Hong Kong
Last updated: February 1, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

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

516 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesGastrointestinal DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsGastrointestinal HemorrhagePeptic Ulcer Hemorrhage

Criteria

4 inclusion criteria required to participate
GBS of >= 12

In-patients admitted for reasons other than AUGIB who develop bleeding are also considered for trial enrollment

Overt signs of upper gastrointestinal bleeding (i.e., melena or hematemesis with or without hypotension)

Patients in Hypotensive shock (SBP <= 90 mmHg or pulse >= 110 bpm) are initially resuscitated and then considered for trial entry if their condition can be stabilized

5 exclusion criteria prevent from participating
18 years of age

Moribund patients from terminal illnesses. (active treatment not considered)

Pregnant or lactating women

Unable to provide written informed consent

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Oesophagogastroduodenoscopy done within 6hours of first GI specialists consultation

Group II

Placebo
Oesophagogastroduodenoscopy done within 24hours of first GI specialists consultation

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Endoscopy Centre, Prince of Wales Hospital

Hong Kong, ChinaOpen Endoscopy Centre, Prince of Wales Hospital in Google Maps
CompletedOne Study Center