Multicenter Validation on Predicting Mortality for Patients With Bleeding Peptic Ulcers

Multicenter Prospective Validation Study on the Prediction of In-hospital Mortality Using CU Prediction Model for Patients With Bleeding Peptic Ulcers

This study aimed to validate CU prediction model on mortality for patients with high risk bleeding peptic ulcers after therapeutic endoscopy.

Study Overview

• Status: Completed
• Conditions: Bleeding Peptic Ulcer

Detailed Description

Despite advances in management of patients with bleeding peptic ulcers, mortality is still 10%. We previously reported a prediction score for ulcer bleeding related mortality developed from a local cohort. The risk factors for mortality included patients older than 70, presence of co-morbidity, more than one listed co-morbidity, hematemesis, SBP < 100 mmHg, in-hospital bleeding, rebleeding, and need for surgery.

Study objective This study aimed to validate the prediction of mortality among patients with bleeding peptic ulcers from different Asian countries.

Method Consecutive patients with bleeding peptic ulcers who presented to the study centers in Hong Kong, Japan and Taiwan were recruited after successful primary endoscopic hemostasis. The baseline demographics, ulcer characteristics, the predictive factors, 30 days mortality, rebleeding, hospital stay and need of surgery were recorded. The accuracy of prediction for adverse events including mortality and rebleeding with the prediction risk scoring system would be analysed.

• Study Type: Observational
• Enrollment (Actual): 785

Contacts and Locations

Study Locations

• China
  • Hong Kong SAR, China, 00000
    • Combined Endoscopy Center, Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with bleeding peptic ulcers who required endoscopic therapy

Description

Inclusion Criteria:

1. Patients presented with bleeding peptic ulcers
2. Age > 18 year old
3. Informed consent for the study and OGD

Exclusion Criteria:

1. Unable or refuse to give consent
2. Onset more than 7 days
3. Pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Low risk group; CU Prediction model < 3
High risk group; CU Prediction model >=3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy in prediction of peptic ulcer bleeding related mortality	The CU prediction score would be calculated from addition of all the risk factors scores. . The calculated predictive score collected from the whole group of patients would be analyzed using the receiver operating characteristic (ROC) curve and represented using the area under curve (AUC). An AUC of 0.5 would be interpreted as poor predictive power whereas a value of 1.0 would indicate excellent predictive power.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital stay		30 days
Complication rate		30 days
Mortality difference between high risk and low risk group		30 days
Need of Surgery		30 days
Need of Transfusion	Need of transfusion as represented by number of units transfused	30 days

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: National Taiwan University Hospital; Okayama University; Tokyo University; Tsuyama Central Hospital, Okayama; Hiroshima City Asa Hospital, Hiroshima; Mitoyo General Hospital
• Investigators: Principal Investigator: Philip Chiu, MD, Department of Surgery, The Chinese University of Hong Kong

Publications and helpful links

General Publications

• Chiu PW, Ng EK, Cheung FK, Chan FK, Leung WK, Wu JC, Wong VW, Yung MY, Tsoi K, Lau JY, Sung JJ, Chung SS. Predicting mortality in patients with bleeding peptic ulcers after therapeutic endoscopy. Clin Gastroenterol Hepatol. 2009 Mar;7(3):311-6; quiz 253. doi: 10.1016/j.cgh.2008.08.044. Epub 2008 Sep 13.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: September 16, 2014
• First Submitted That Met QC Criteria: September 19, 2014
• First Posted (Estimate): September 22, 2014

Study Record Updates

• Last Update Posted (Estimate): September 22, 2014
• Last Update Submitted That Met QC Criteria: September 19, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Mortality; Prediction model; Bleeding peptic ulcer; Prediction of in-hospital mortality for bleeding peptic ulcer
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Duodenal Diseases; Gastrointestinal Hemorrhage; Ulcer; Hemorrhage; Peptic Ulcer; Peptic Ulcer Hemorrhage
• Other Study ID Numbers: CRE-2010.207