Standard Endoscopic Hemostasis Versus OVESCO Severe Non-variceal UGI Hemorrhage

Launched by CURE DIGESTIVE DISEASES RESEARCH CENTER · Feb 22, 2017

Keywords

ClinConnect Summary

This clinical trial is comparing two methods for treating severe upper gastrointestinal bleeding, which can happen due to conditions like ulcers or Dieulafoy's lesions. Researchers want to see if using a new device called an over-the-scope clip, which is designed to help stop bleeding, is more effective than the standard method currently used. The main focus is to find out how many patients experience rebleeding within 30 days after treatment.

To participate in this trial, patients must be between 65 and 99 years old and show clear signs of severe upper gastrointestinal bleeding that can be treated. They should have a specific type of bleeding ulcer or lesion that looks benign. It's important for patients to provide written consent to join the study. If selected, participants will receive one of the two treatment options and be monitored for their recovery and any complications. This trial is currently recruiting participants, and it aims to improve treatment options for those experiencing severe bleeding in the upper digestive system.

Gender

ALL

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.