Multicenter Validation on Predicting Mortality for Patients With Bleeding Peptic Ulcers

NCT ID: NCT02245802

Last Updated: 2014-09-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 785 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-04-30

Brief Summary

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

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.

Conditions

Bleeding Peptic Ulcer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Low risk group

CU Prediction model \< 3

No interventions assigned to this group

High risk group

CU Prediction model \>=3

No interventions assigned to this group

Eligibility Criteria

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

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

Sponsors

Tokyo University

OTHER

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: collaborator

Tsuyama Central Hospital, Okayama

UNKNOWN

Sponsor Role: collaborator

Hiroshima City Asa Hospital, Hiroshima

UNKNOWN

Sponsor Role: collaborator

Mitoyo General Hospital

UNKNOWN

Sponsor Role: collaborator

Okayama University

OTHER

Sponsor Role: collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Philip Wai Yan Chiu

Professor, Department of Surgery, Institute of Digestive Disease

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philip Chiu, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, The Chinese University of Hong Kong

Locations

Combined Endoscopy Center, Prince of Wales Hospital

Hong Kong SAR, , China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 18955161 (View on PubMed)

Other Identifiers

CRE-2010.207

Identifier Type: -

Identifier Source: org_study_id