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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Urgent endoscopy | Active Comparator | Oesophagogastroduodenoscopy done within 6hours of first GI specialists consultation |
|
| Early endoscopy | Placebo Comparator | Oesophagogastroduodenoscopy done within 24hours of first GI specialists consultation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urgent endoscopy | Other | Defined by oesophagogastroduodenoscopy within 6 hours of first presentation of Prince of Wales Hospital |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Death from all causes 30 days from randomization | 30 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Y LAU, MD | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endoscopy Centre, Prince of Wales Hospital | Hong Kong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32242355 | Derived | Lau JYW, Yu Y, Tang RSY, Chan HCH, Yip HC, Chan SM, Luk SWY, Wong SH, Lau LHS, Lui RN, Chan TT, Mak JWY, Chan FKL, Sung JJY. Timing of Endoscopy for Acute Upper Gastrointestinal Bleeding. N Engl J Med. 2020 Apr 2;382(14):1299-1308. doi: 10.1056/NEJMoa1912484. |
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| ID | Term |
|---|---|
| D010438 | Peptic Ulcer Hemorrhage |
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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Patients are randomized in a 1:1 ratio. The patient is randomized to receive;
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| Early endoscopy | Other | Defined by oesophagogastroduodenoscopy within 24 hours of first presentation of Prince of Wales Hospital |
|
| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |