Clinical trial NCT01675856: Urgent vs. Early Endoscopy in High Risk Patients With Upper Gastrointestinal Bleeding (UGIB)
Official title: Urgent vs. Early Endoscopy in High Risk Patients With UGIB
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bleeding Peptic Ulcer
Active Bleeding
Gastrointestinal Bleeding
Keywords: Glasgow-Blatchford score
Gastrointestinal bleeding
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2012-08-30
Enrollment: 516
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomized in a 1:1 ratio. The patient is randomized to receive;

1. Urgent endoscopy (defined by endoscopy within 6 hours from first consultation by GI specialists at PWH) or
2. Early endoscopy (defined by endoscopy next morning and within 24 hours from first consultation by GI specialists at PWH)
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

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)

Primary outcomes:
measure: Mortality
timeFrame: 30 days
Secondary outcomes:
measure: Need for endoscopic therapy at index endoscopy
timeFrame: At the time of index endoscopy
measure: Need for transfusion
timeFrame: Within 30days of randomization
measure: Recurrent bleeding as defined
timeFrame: Within 30days of randomization
measure: Duration of hospital stay of index bleeding
timeFrame: Within 30 days of randomization
measure: ICU stay
timeFrame: Within 30days of randomization
measure: Need for further endoscopic treatment
timeFrame: Within 30days of randomization
measure: Emergency surgery or interventional radiology to achieve hemostasis
timeFrame: Within 30days of randomization
measure: Rates of recurrent bleeding
timeFrame: Within 30 days of randomization
measure: Rate of adverse events
timeFrame: Within 30 days of randomization
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Endoscopy Centre, Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: James Y LAU, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.