Standard Endoscopic Hemostasis Versus OVESCO Severe Non-variceal UGI Hemorrhage

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, 27% of patients in referral hospitals with
upper gastrointestinal bleeding (UGIB) from ulcers or other non-variceal UGI lesions (NVUGI)
have refractory or recurrent bleeding in a recent RCT by our group. Potential risk factors
for NVUGI bleeding lesions were large ulcers (≥ 15 mm), fibrotic base, Dieulafoy's lesions,
anastomotic ulcers, coagulopathies, cirrhosis, severe co-morbidities, and residual arterial
blood flow under stigmata after endoscopic hemostasis. Such patients with severe 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 larger underlying arteries than standard hemoclips and
potentially could improve endoscopic hemostasis of such bleeding lesions.

Inclusion Criteria:

- Written informed consent from the patient or a surrogate.

- Clinical evidence of severe UGIB.

- Presence of a benign appearing peptic ulcer, post-Endoscopic mucosal resection (EMR)
ulcer, anastomotic ulcer, Dieulafoy's lesion, or UGI post-polypectomy induced ulcer
with some SRH on endoscopy.

- Severe bleeding, refractory bleeding, or recurrent 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
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, 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,
peritonitis, or unstable cardiopulmonary status).

- Stricture of the esophagus or pylorus that can not be dilated or precludes passage of
a 12 mm diameter endoscope and/or GI endoscope with the large hemoclipping
device-Ovesco.