Urgent vs. Early Endoscopy in High Risk Patients With Upper Gastrointestinal Bleeding (UGIB)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Urgent vs. Early Endoscopy in High Risk Patients With UGIB

Conditions
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Bleeding Peptic Ulcer, Active Bleeding, Gastrointestinal Bleeding

Intervention / Treatment
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* Other: Urgent endoscopy
* Other: Early endoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overt signs of upper gastrointestinal bleeding (i.e., melena or hematemesis with or without hypotension) GBS of ≥12 In-patients admitted for reasons other than AUGIB who develop bleeding are also considered for trial enrollment. 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. Exclusion Criteria: continued shock despite initial volume resuscitation (refractory shock) undergo urgent endoscopy < 18 years of age Unable to provide written informed consent Pregnant or lactating women Moribund patients from terminal illnesses. (active treatment not considered)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients are randomized in a 1:1 ratio. The patient is randomized to receive; Urgent endoscopy (defined by endoscopy within 6 hours from first consultation by GI specialists at PWH) or Early endoscopy (defined by endoscopy next morning and within 24 hours from first consultation by GI specialists at PWH)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Urgent endoscopy<br>Oesophagogastroduodenoscopy done within 6hours of first GI specialists consultation | Other: Urgent endoscopy<br>* Defined by oesophagogastroduodenoscopy within 6 hours of first presentation of Prince of Wales Hospital<br>|
| Placebo Comparator: Early endoscopy<br>Oesophagogastroduodenoscopy done within 24hours of first GI specialists consultation | Other: Early endoscopy<br>* Defined by oesophagogastroduodenoscopy within 24 hours of first presentation of Prince of Wales Hospital<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Death from all causes 30 days from randomization | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for endoscopic therapy at index endoscopy | To measure if endoscopic therapy is needed at the index endoscopy | At the time of index endoscopy | 
| Need for transfusion | To measure if transfusion of blood products is needed within 30days of randomization | Within 30days of randomization | 
| Recurrent bleeding as defined | To measure if any clinical or endoscopic recurrent bleeding is identified. | 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. | Within 30 days of randomization | 
| ICU stay | To measure if ICU admission is required at the index bleeding. | Within 30days of randomization | 
| Need for further endoscopic treatment | To measure if further endoscopic treatment if required at recurrent bleeding | 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 | Within 30days of randomization | 
| Rates of recurrent bleeding | To measure recurrent bleeding in both study arms | 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. | Within 30 days of randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glasgow-Blatchford score, Gastrointestinal bleeding