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

Not Applicable

Completed

• Conditions: Bleeding Peptic Ulcer; Active Bleeding; Gastrointestinal Bleeding
• Interventions: Other: Early endoscopy; Other: Urgent endoscopy

• Registration Number: NCT01675856
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-07-28
• Study First Submitted: 2012-08-27
• Study First Submitted QC: 2012-08-28
• Study First Posted: 2012-08-30
• Primary Completion: 2018-11-11
• Study Completion: 2018-11-11
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 516

Inclusion Criteria

1. Overt signs of upper gastrointestinal bleeding (i.e., melena or hematemesis with or without hypotension)
2. GBS of ≥12
3. In-patients admitted for reasons other than AUGIB who develop bleeding are also considered for trial enrollment.
4. 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.

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Exclusion Criteria

1. continued shock despite initial volume resuscitation (refractory shock) undergo urgent endoscopy
2. < 18 years of age
3. Unable to provide written informed consent
4. Pregnant or lactating women
5. Moribund patients from terminal illnesses. (active treatment not considered)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early endoscopy	Early endoscopy	Oesophagogastroduodenoscopy done within 24hours of first GI specialists consultation
Urgent endoscopy	Urgent endoscopy	Oesophagogastroduodenoscopy done within 6hours of first GI specialists consultation

Primary Outcome Measures

Name	Time	Method
Mortality	30 days	Death from all causes 30 days from randomization

Secondary Outcome Measures

Name	Time	Method
Need for endoscopic therapy at index endoscopy	At the time of index endoscopy	To measure if endoscopic therapy is needed at the index endoscopy
Need for transfusion	Within 30days of randomization	To measure if transfusion of blood products is needed within 30days of randomization
Recurrent bleeding as defined	Within 30days of randomization	To measure if any clinical or endoscopic recurrent bleeding is identified.
Duration of hospital stay of index bleeding	Within 30 days of randomization	To measure the number of days of hospital stay upon randomization, only counted the hospitalization days of index bleeding.
ICU stay	Within 30days of randomization	To measure if ICU admission is required at the index bleeding.
Need for further endoscopic treatment	Within 30days of randomization	To measure if further endoscopic treatment if required at recurrent bleeding
Emergency surgery or interventional radiology to achieve hemostasis	Within 30days of randomization	To measure if emergency surgery or interventional radiology is needed at index bleeding or recurrent bleeding to achieve hemostasis
Rates of recurrent bleeding	Within 30 days of randomization	To measure recurrent bleeding in both study arms
Rate of adverse events	Within 30 days of randomization	To measure the adverse events in either group, e.g. myocardial event, cerebrovascular event and acute renal failure.

Trial Locations

Locations (1)

Endoscopy Centre, Prince of Wales Hospital; 🇨🇳 Hong Kong, China