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

NCT ID: NCT01675856

Last Updated: 2019-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 516 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-28
• Study Completion Date: 2018-11-11

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.

Conditions

Bleeding Peptic Ulcer; Active Bleeding; Gastrointestinal Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Urgent endoscopy

Oesophagogastroduodenoscopy done within 6hours of first GI specialists consultation

Group Type: ACTIVE_COMPARATOR

Urgent endoscopy

Intervention Type: OTHER

Defined by oesophagogastroduodenoscopy within 6 hours of first presentation of Prince of Wales Hospital

Early endoscopy

Oesophagogastroduodenoscopy done within 24hours of first GI specialists consultation

Group Type: PLACEBO_COMPARATOR

Early endoscopy

Intervention Type: OTHER

Defined by oesophagogastroduodenoscopy within 24 hours of first presentation of Prince of Wales Hospital

Interventions

Urgent endoscopy

Defined by oesophagogastroduodenoscopy within 6 hours of first presentation of Prince of Wales Hospital

Intervention Type: OTHER

Early endoscopy

Defined by oesophagogastroduodenoscopy within 24 hours of first presentation of Prince of Wales Hospital

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

James Yun-wong Lau

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James Y LAU, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Endoscopy Centre, Prince of Wales Hospital

Hong Kong, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 32242355 (View on PubMed)

Other Identifiers

AUGIB

Identifier Type: -

Identifier Source: org_study_id