NCT01675856

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

Urgent vs. Early Endoscopy in High Risk Patients With UGIB

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 516 (actual)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Urgent endoscopy	Defined by oesophagogastroduodenoscopy within 6 hours of first presentation of Prince of Wales Hospital
OTHER	Early endoscopy	Defined by oesophagogastroduodenoscopy within 24 hours of first presentation of Prince of Wales Hospital

Timeline

• Start date: 2012-07-28
• Primary completion: 2018-11-11
• Completion: 2018-11-11
• First posted: 2012-08-30
• Last updated: 2019-02-01

Locations

1 site across 1 country: China