Ulcer Bleeding Clinical Trial
Official title:
The Use of Over-the-scope-clip (OTSC) Versus Standard Therapy for the Prevention of Rebleeding in High Risk Peptic Ulcers: a Randomised Controlled Trial.
Verified date | July 2022 |
Source | Chinese University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Non-variceal acute gastrointestinal bleeding is a common and potentially life-threatening problem. The conventional treatment of this condition is for esophagogastroduodenoscopy (OGD) for haemostasis. Treatment methods include heater probe, clipping and injection of adrenaline. Recently, a new device called the Over-the-scope clip (OTSC) has been device to treat perforations and bleeding in the gastrointestinal tract. Therefore, the aim of the study is to compare between the treatment outcomes between OTSC and conventional endoscopic haemostatic methods in ulcers that are of high risk for rebleeding.
Status | Completed |
Enrollment | 100 |
Est. completion date | February 28, 2022 |
Est. primary completion date | August 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Actively bleeding peptic ulcers (Forrest Ia, Ib), ulcers with non-bleeding visible vessel or Forrest IIa ulcer (defined as protuberant discoloration, or ulcers with an initial clot and upon irrigation shows a vessel) AND 2. Ulcer size = 1.5 cm as determined by an opened biopsy forceps; Exclusion Criteria: 1. Patients aged below 18 2. Peptic ulcer with concomitant perforation 3. Tumor bleeding 4. Variceal bleeding 5. Patients who are pregnant or lactating 6. Moribund patients or patients with terminal malignancy or end-stage non-malignant conditions, in whom life expectancy is less than 30 days |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Prince of Wales Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The number of cases that develop clinical rebleeding | Clinical rebleeding is defined as fresh hematemesis, fresh melena or hematochezia and signs of hypovolemic shock (systolic blood pressure of <90mmHg and pulse rate >110 per minute) and/or a drop in hemoglobin of > 2 g/dl per 24 hours despite adequate transfusion. Rebleeding would be confirmed by an immediate endoscopy showing fresh blood in stomach or active bleeding from a previously seen ulcer. A clinical rebleeding will be independently reviewed by an adjudication panel. | Within 30 days of therapy | |
Secondary | Number of cases that died | Death from all causes within 30 days of therapy | within 30 days of therapy | |
Secondary | Number of units of blood transfusion required in each patient | Number of units of blood transfusion required in each patient within 30 days of therapy | within 30 days of therapy | |
Secondary | Hospital stay | Hospital stay for the episode of bleeding | up to one year | |
Secondary | Number of cases with failure of achieving primary haemostasis | The number of cases with failure of achieving primary haemostasis. Failure of primary haemostasis is defined by the inability to achieve haemostasis during the index endoscopy. | Within 30 days of therapy | |
Secondary | The number of cases requiring further interventions such as repeat endoscopy, surgery or transarterial embolization | The number of cases requiring further interventions such as repeat endoscopy, surgery or transarterial embolization | Within 30 days of therapy | |
Secondary | Hospital costs | The total direct costs required for the hospital admission for the episode of bleeding measured in Hong Kong dollars | Up to one year |
Status | Clinical Trial | Phase | |
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Completed |
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