Standard Endoscopic Hemostasis Versus OVESCO Severe Non-variceal UGI Hemorrhage

  • STATUS
    Recruiting
  • End date
    Feb 28, 2023
  • participants needed
    65
  • sponsor
    CURE Digestive Diseases Research Center
Updated on 14 April 2022
Accepts healthy volunteers

Summary

The primary specific aim is to perform a randomized controlled trial (RCT) to compare 30 day rebleed rates and other clinical outcomes of patients with severe, non-variceal upper GI hemorrhage (NVUGIH) - ulcers and Dieulafoy's lesions who are randomized as initial treatment with the new large over-the-scope-clip device for endoscopic hemostasis versus standard endoscopic hemostasis.

Description

Upper GI Hemorrhage (UGIH) causes significant morbidity and mortality, although endoscopic hemostasis has revolutionized management of these patients. Despite standard endoscopic treatment and high dose proton pump infusions, 25% - 30% of high risk patients with UGIB from ulcers or other non-variceal UGI lesions (NVUGI) had recurrent bleeding in a recent RCT and cohort studies by our group. Potential risk factors for NVUGI rebleeding were large ulcers (≥ 15 mm), fibrotic bases, Dieulafoy's lesions, anastomotic ulcers, coagulopathies, cirrhosis, other severe co-morbidities and residual arterial blood flow under stigmata of recent hemorrhage (SRH) after endoscopic treatment. Such patients with rebleeding after standard endoscopic hemostasis usually required angiography (by interventional radiologists-IR) or surgery for definitive hemostasis. A new, large, FDA approved, over-the-scope hemoclipping device (OTSC® System OVESCO Endoscopy, Tübingen, Germany) can capture larger amounts of tissue and underlying arteries than standard hemoclips and potentially can improve endoscopic hemostasis of such bleeding lesions.

Details
Condition Upper Gastrointestinal Hemorrhage
Treatment Over-the-scope hemoclipping device, Standard endoscopic treatment
Clinical Study IdentifierNCT03065465
SponsorCURE Digestive Diseases Research Center
Last Modified on14 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Written informed consent from the patient or a surrogate
Clinical evidence of severe UGIB
Presence of a benign appearing peptic ulcer, anastomotic ulcer, or Dieulafoy's lesion, with some SRH on endoscopy
Severe upper GI bleeding
Life expectancy of at least 30 days based on lack of severe or terminal comorbidity as judged by the generalist or subspecialist caring for the patient

Exclusion Criteria

Patients who are do-not-resuscitate (DNR) that is not reversible, uncooperative, refuse to participate, or are unable to give consent personally or through a legal surrogate
Active GI malignancy, under treatment but not in remission
Acute hypovolemic shock that is unresponsive to transfusion of 5 or more units of red blood cells (RBC's) or requires continuous intravenous vasopressor infusion for blood pressure support
ASA (American Society of Anesthesiology) class V or higher, moribund, or with a very poor prognosis and expected survival <30 days
Severe coagulopathy or thrombocytopenia despite attempted reversal with transfusion of blood products (e.g persistent International Normalized Ratio [INR] >2.0, platelet count <20,000, a Partial Thromboplastin Time [PTT] greater than 2x upper limit of normal)
Absolute contraindication to urgent endoscopy (such as suspected perforated viscus, or peritonitis)
Stricture of the esophagus or pylorus that can not be dilated or precludes passage of a diagnostic sized endoscope and/or the GI endoscope with an 11, 3a OTSC device attached
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