An interventional study of Urgent endoscopy and Early endoscopy in Bleeding Peptic Ulcer, Active Bleeding and Gastrointestinal Bleeding, sponsored by Chinese University of Hong Kong. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-01.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Diagnostic
Acute upper gastrointestinal bleeding (UGIB) is one of the commonest medical emergencies. The condition accounts for 150 per 100,000 populations. A National United Kingdom reported a crude overall mortality rate of 10%. While bleeding stops spontaneously in majority of patients at their presentation, there remains a subgroup of patients who continue to bleed or develop recurrent bleeding. In these patients, the mortality increases manifolds. If these high-risk patients can be identified, early interventions may improve their outcomes.
Several prognostic indices are in use for the purpose of patient stratification. They include the Rockall, Glasgow-Blatchford (GBS) and the Baylor scores. The Rockall score is a composite score which incorporates clinical parameters as well as findings during endoscopy which was derived to predict mortality. The GBS is a pre-endoscopy or a clinical score for the prediction for the need of further intervention loosely defined as the need for transfusion, endoscopy or surgery. It has been shown to be accurate in identifying low risk patients for early discharge.
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.
339 studies on the registry are indexed under Gastrointestinal Hemorrhage; 79 are open to participants now.
This study's enrollment of 516 is above the median of 87 across 211 interventional studies indexed under Gastrointestinal Hemorrhage.
Browse Gastrointestinal Hemorrhage studies →Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
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Exclusion Criteria:
Oesophagogastroduodenoscopy done within 6hours of first GI specialists consultation
Other: Urgent endoscopy
Oesophagogastroduodenoscopy done within 24hours of first GI specialists consultation
Other: Early endoscopy
Defined by oesophagogastroduodenoscopy within 6 hours of first presentation of Prince of Wales Hospital
Defined by oesophagogastroduodenoscopy within 24 hours of first presentation of Prince of Wales Hospital
Mortality
Death from all causes 30 days from randomization
Time frame: 30 days
Need for endoscopic therapy at index endoscopy
To measure if endoscopic therapy is needed at the index endoscopy
Time frame: At the time of index endoscopy
Need for transfusion
To measure if transfusion of blood products is needed within 30days of randomization
Time frame: Within 30days of randomization
Recurrent bleeding as defined
To measure if any clinical or endoscopic recurrent bleeding is identified.
Time frame: Within 30days of randomization
Duration of hospital stay of index bleeding
To measure the number of days of hospital stay upon randomization, only counted the hospitalization days of index bleeding.
Time frame: Within 30 days of randomization
ICU stay
To measure if ICU admission is required at the index bleeding.
Time frame: Within 30days of randomization
Need for further endoscopic treatment
To measure if further endoscopic treatment if required at recurrent bleeding
Time frame: Within 30days of randomization
Emergency surgery or interventional radiology to achieve hemostasis
To measure if emergency surgery or interventional radiology is needed at index bleeding or recurrent bleeding to achieve hemostasis
Time frame: Within 30days of randomization
Rates of recurrent bleeding
To measure recurrent bleeding in both study arms
Time frame: Within 30 days of randomization
Rate of adverse events
To measure the adverse events in either group, e.g. myocardial event, cerebrovascular event and acute renal failure.
Time frame: Within 30 days of randomization
Plan to share: No
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong