Summary

for people ages 18-100 (full criteria)
healthy people welcome
at UCLA
study started
estimated completion:
Dennis M Jensen (ucla)

Description

Summary

The primary specific aim is to perform a randomized controlled trial (RCT) to compare the rebleeding rates and other clinical outcomes of severe, refractory or recurrent non-variceal upper GI hemorrhage (NVUGIH) with a new over-the-scope hemoclipping device (OVESCO) 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, 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.

Keywords

Upper Gastrointestinal Hemorrhage Upper GI hemorrhage Stigmata of recent hemorrhage Diverticular Hemorrhage Ulcers Hemorrhage Gastrointestinal Hemorrhage Hemostatics Over-the-scope hemoclipping device Standard endoscopic treatment

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, 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.

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 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.

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

  • Dennis M Jensen (ucla)
    Director, Hemostasis Program. Authored (or co-authored) 58 research publications

Details

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