Clinical trial NCT03065465: Standard Endoscopic Hemostasis Versus OVESCO Severe Non-variceal UGI Hemorrhage
Official title: Randomized Controlled Trial (RCT) of Standard Endoscopic Hemostasis Compared to OVESCO for Severe Non-variceal UGI Hemorrhage
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Upper Gastrointestinal Hemorrhage
Keywords: Upper GI hemorrhage
Stigmata of recent hemorrhage
Ulcers
Dieulafoy's lesions
Lead sponsor: CURE Digestive Diseases Research Center
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: VA Greater Los Angeles Healthcare System
First posted: 2017-02-28
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The rebleeding rate of non-variceal focal UGI lesions
timeFrame: Outcome measure will be assessed at 30 days after participants are enrolled
Secondary outcomes:
measure: Obliteration rates of underlying arterial blood flow (detected by Doppler endoscopic probe)
timeFrame: Outcome measure will be assessed at 30 days after the endoscopy treatment is completed
measure: Rates of surgery or IR, complications, and death
timeFrame: Outcome measure will be assessed at 30 days after participants are enrolled
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Dennis M Jensen, MD
role: PRINCIPAL_INVESTIGATOR
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