Summary

Eligibility
for people ages 18-100 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Dennis M Jensen (ucla)

Description

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.

Official Title

Randomized Controlled Trial (RCT) of Standard Endoscopic Hemostasis Compared to OVESCO for Severe Non-variceal UGI Hemorrhage

Details

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.

Keywords

Upper Gastrointestinal Hemorrhage Upper GI hemorrhage Stigmata of recent hemorrhage Ulcers Dieulafoy's lesions Gastrointestinal Hemorrhage Hemorrhage Over-the-scope hemoclipping device

Eligibility

You can join if…

Open to people ages 18-100

  • 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.

You CAN'T join if...

  • 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.

Locations

  • University of California, Los Angeles accepting new patients
    Los Angeles California 90095 United States
  • VA Greater Los Angeles Healthcare System accepting new patients
    Los Angeles California 90073 United States

Lead Scientist at University of California Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
CURE Digestive Diseases Research Center
ID
NCT03065465
Study Type
Interventional
Last Updated