Role of Doppler Ultrasound in Severe Peptic Ulcer Hemorrhage

The Chinese University of Hong Kong

Status: Terminated

Conditions: Peptic Ulcer Hemorrhage

Treatments: Device: Doppler ultrasound probe

Study type: Interventional

Funder types: Other

Identifiers

NCT00164905

DOP-US study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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121 participants in 2 patient groups

Doppler ultrasound

Active Comparator group

Treatment:

Device: Doppler ultrasound probe

No Doppler ultrasound

No Intervention group