Role of Doppler Ultrasound in Severe Peptic Ulcer Hemorrhage

Peptic Ulcer Hemorrhage Clinical Trial

Official title:

Role of Doppler Ultrasound in Severe Peptic Ulcer Hemorrhage: Can it Guide the Use of and Predict Failure of Endoscopic Treatment? A Prospective, Multicenter, Randomized, Controlled Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00164905
• Other study ID #: DOP-US study
• Status: Terminated
• Phase: N/A
• First received: September 12, 2005
• Last updated: August 27, 2012
• Start date: September 2004
• Est. completion date: August 2010

Study information

• Verified date: August 2012
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial Summary

The aim of study is to evaluate whether Doppler ultrasound can accurately identify patients who are at risk of recurrent bleeding, who will require endoscopic therapy, and who will fail endoscopic therapy.

Description:

Bleeding peptic ulcer is a life-threatening emergency. Endoscopic therapy is a proven technique in the acute hemostasis of bleeding ulcers. Currently there is no objective assessment of adequacy of endoscopic therapy. Endoscopic Doppler ultrasound enables endoscopists in detecting blood flow in a vessel beneath an ulcer. A persistent signal after endoscopic therapy predicts recurrent bleeding. The current study proposes to compare assessment of ulcer base using either Doppler ultrasound or endoscopists' interpretation of ulcer floors. The trial design is one of a prospective randomized controlled cross-over study in which patients with severe upper gastrointestinal bleeding and documented peptic ulcers at endoscopy are enrolled.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 121
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clean base ulcer with severe upper GIB (defined as melaena, hematochezia, hematemesis, and/or gross blood in NG lavage), and any one of the following:

1. SBP = 90mmHg; P of =110 bpm; or orthostatic changes with SBP drops 20mmHg or P increases 20 bpm; or,

2. Transfusion of 2 or more units of packed red blood cells within 12 hrs of admission; or,

3. A documented HCT drop of at lest 6% from baseline.

• Endoscopically confirmed bleeding from GU, DU, pyloric ulcer, or anastomotic ulcer

• Pt can either have primary or secondary acute UGI haemorrhage

Exclusion Criteria:

• Bleeding site from lesion other than GU, DU, pyloric or anastomotic ulcer

• there is more than one type of significant bleeding lesion

• Documented hx of cirrhosis / portal HT

• ESRF requiring any form of dialysis

• Expected or persistent (>24hrs) coagulopathy with INR> 1.5

• Platelet count is under 50000/mm3

• Aspirin User / Plavix [Clopidogrel] User

• If the ulcer is neoplastic

• Cannot obtained consent

• Age < 18 or is pregnant

• Severe comorbid of which life expectancy <30 days

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Peptic Ulcer
• Peptic Ulcer Hemorrhage
• Ulcer

Intervention

Device:
• Doppler ultrasound probe
Applying to ulcer base to assess the blood flow underneath the ulcer

Locations

Country	Name	City	State
China	Endoscopy Center, Prince of Wales Hospital	Hong Kong SAR

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	University Hospital Case Medical Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent bleeding		Within 30 days	No
Secondary	Length of stay		Within 56 days	No
Secondary	ICU utilization		Within 56 days	No
Secondary	Blood Transfusion during hospital		Within 56 days	No
Secondary	Need for urgent/emergent ulcer surgery for bleeding		Within 56 days	No
Secondary	Need for angiographic treatment of bleeding		Within 56 days	No
Secondary	Death		within 56 days	No