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

Urgent vs. Early Endoscopy in High Risk Patients With UGIB

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Bleeding; Bleeding Peptic Ulcer; Active Bleeding
• Intervention / Treatment: Other: Urgent endoscopy; Other: Early endoscopy

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 Type: Interventional
• Enrollment (Actual): 516
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • Endoscopy Centre, Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: James Y Lau, MD, Chinese University of Hong Kong

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2012
• Primary Completion (Actual): November 11, 2018
• Study Completion (Actual): November 11, 2018

Study Registration Dates

• First Submitted: August 27, 2012
• First Submitted That Met QC Criteria: August 28, 2012
• First Posted (Estimate): August 30, 2012

Study Record Updates

• Last Update Posted (Actual): February 1, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Gastrointestinal bleeding; Glasgow-Blatchford score
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Duodenal Diseases; Hemorrhage; Peptic Ulcer; Gastrointestinal Hemorrhage; Peptic Ulcer Hemorrhage
• Other Study ID Numbers: AUGIB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No