Comparing two methods for treating severe upper gastrointestinal bleeding

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

This study is testing a new device for stopping severe upper gastrointestinal bleeding to see if it works better than the standard treatment for patients with conditions like ulcers.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 65 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: CURE Digestive Diseases Research Center (other)
• Locations: 2 sites (Los Angeles, California and 1 other locations)
• Trial ID: NCT03065465 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effectiveness of a new over-the-scope hemoclipping device with standard endoscopic treatment for patients suffering from severe non-variceal upper gastrointestinal hemorrhage. The study will randomly assign participants to receive either the new device or standard treatment and will evaluate outcomes such as rebleeding rates and other clinical results over a 30-day period. The trial focuses on patients with specific conditions like ulcers and Dieulafoy's lesions, which are known to have high rebleeding risks. By assessing these two approaches, the study seeks to determine if the new device can improve patient outcomes in this critical area of care.

Who should consider this trial

Good fit: Ideal candidates for this study are patients with severe upper gastrointestinal bleeding due to benign ulcers or Dieulafoy's lesions who are at high risk for rebleeding.

Not a fit: Patients with active gastrointestinal malignancies, those in acute hypovolemic shock, or with a very poor prognosis are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options and reduced rebleeding rates for patients with severe upper gastrointestinal hemorrhage.

How similar studies have performed: Previous studies have indicated that endoscopic hemostasis is effective, but this specific approach using the over-the-scope device is novel and has not been extensively tested.

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.

Where this trial is running

Los Angeles, California and 1 other locations

• VA Greater Los Angeles Healthcare System — Los Angeles, California, United States (RECRUITING)
• University of California, Los Angeles — Los Angeles, California, United States (RECRUITING)

Study contacts

• Principal investigator: Dennis M Jensen, MD — University of California, Los Angeles
• Study coordinator: Dennis M Jensen, MD

Conditions: Upper Gastrointestinal Hemorrhage, Upper GI hemorrhage, Stigmata of recent hemorrhage, Ulcers, Dieulafoy's lesions