Urgent vs. Early Endoscopy in High Risk Patients With Upper Gastrointestinal Bleeding (UGIB)
Primary Purpose
Bleeding Peptic Ulcer, Active Bleeding, Gastrointestinal Bleeding
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Urgent endoscopy
Early endoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Bleeding Peptic Ulcer focused on measuring Glasgow-Blatchford score, Gastrointestinal bleeding
Eligibility Criteria
Inclusion Criteria:
- Overt signs of upper gastrointestinal bleeding (i.e., melena or hematemesis with or without hypotension)
- GBS of ≥12
- In-patients admitted for reasons other than AUGIB who develop bleeding are also considered for trial enrollment.
- 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:
- continued shock despite initial volume resuscitation (refractory shock) undergo urgent endoscopy
- < 18 years of age
- Unable to provide written informed consent
- Pregnant or lactating women
- Moribund patients from terminal illnesses. (active treatment not considered)
Sites / Locations
- Endoscopy Centre, Prince of Wales Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Urgent endoscopy
Early endoscopy
Arm Description
Oesophagogastroduodenoscopy done within 6hours of first GI specialists consultation
Oesophagogastroduodenoscopy done within 24hours of first GI specialists consultation
Outcomes
Primary Outcome Measures
Mortality
Death from all causes 30 days from randomization
Secondary Outcome Measures
Need for endoscopic therapy at index endoscopy
To measure if endoscopic therapy is needed at the index endoscopy
Need for transfusion
To measure if transfusion of blood products is needed within 30days of randomization
Recurrent bleeding as defined
To measure if any clinical or endoscopic recurrent bleeding is identified.
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.
ICU stay
To measure if ICU admission is required at the index bleeding.
Need for further endoscopic treatment
To measure if further endoscopic treatment if required at recurrent bleeding
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
Rates of recurrent bleeding
To measure recurrent bleeding in both study arms
Rate of adverse events
To measure the adverse events in either group, e.g. myocardial event, cerebrovascular event and acute renal failure.
Full Information
NCT ID
NCT01675856
First Posted
August 27, 2012
Last Updated
January 31, 2019
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01675856
Brief Title
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
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
July 28, 2012 (Actual)
Primary Completion Date
November 11, 2018 (Actual)
Study Completion Date
November 11, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding Peptic Ulcer, Active Bleeding, Gastrointestinal Bleeding
Keywords
Glasgow-Blatchford score, Gastrointestinal bleeding
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients are randomized in a 1:1 ratio. The patient is randomized to receive;
Urgent endoscopy (defined by endoscopy within 6 hours from first consultation by GI specialists at PWH) or
Early endoscopy (defined by endoscopy next morning and within 24 hours from first consultation by GI specialists at PWH)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
516 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Urgent endoscopy
Arm Type
Active Comparator
Arm Description
Oesophagogastroduodenoscopy done within 6hours of first GI specialists consultation
Arm Title
Early endoscopy
Arm Type
Placebo Comparator
Arm Description
Oesophagogastroduodenoscopy done within 24hours of first GI specialists consultation
Intervention Type
Other
Intervention Name(s)
Urgent endoscopy
Intervention Description
Defined by oesophagogastroduodenoscopy within 6 hours of first presentation of Prince of Wales Hospital
Intervention Type
Other
Intervention Name(s)
Early endoscopy
Intervention Description
Defined by oesophagogastroduodenoscopy within 24 hours of first presentation of Prince of Wales Hospital
Primary Outcome Measure Information:
Title
Mortality
Description
Death from all causes 30 days from randomization
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Need for endoscopic therapy at index endoscopy
Description
To measure if endoscopic therapy is needed at the index endoscopy
Time Frame
At the time of index endoscopy
Title
Need for transfusion
Description
To measure if transfusion of blood products is needed within 30days of randomization
Time Frame
Within 30days of randomization
Title
Recurrent bleeding as defined
Description
To measure if any clinical or endoscopic recurrent bleeding is identified.
Time Frame
Within 30days of randomization
Title
Duration of hospital stay of index bleeding
Description
To measure the number of days of hospital stay upon randomization, only counted the hospitalization days of index bleeding.
Time Frame
Within 30 days of randomization
Title
ICU stay
Description
To measure if ICU admission is required at the index bleeding.
Time Frame
Within 30days of randomization
Title
Need for further endoscopic treatment
Description
To measure if further endoscopic treatment if required at recurrent bleeding
Time Frame
Within 30days of randomization
Title
Emergency surgery or interventional radiology to achieve hemostasis
Description
To measure if emergency surgery or interventional radiology is needed at index bleeding or recurrent bleeding to achieve hemostasis
Time Frame
Within 30days of randomization
Title
Rates of recurrent bleeding
Description
To measure recurrent bleeding in both study arms
Time Frame
Within 30 days of randomization
Title
Rate of adverse events
Description
To measure the adverse events in either group, e.g. myocardial event, cerebrovascular event and acute renal failure.
Time Frame
Within 30 days of randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Overt signs of upper gastrointestinal bleeding (i.e., melena or hematemesis with or without hypotension)
GBS of ≥12
In-patients admitted for reasons other than AUGIB who develop bleeding are also considered for trial enrollment.
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:
continued shock despite initial volume resuscitation (refractory shock) undergo urgent endoscopy
< 18 years of age
Unable to provide written informed consent
Pregnant or lactating women
Moribund patients from terminal illnesses. (active treatment not considered)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Y LAU, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endoscopy Centre, Prince of Wales Hospital
City
Hong Kong
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32242355
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.
Results Reference
derived
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Urgent vs. Early Endoscopy in High Risk Patients With Upper Gastrointestinal Bleeding (UGIB)
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