RECRUITING

Standard Endoscopic Hemostasis Versus OVESCO Severe Non-variceal UGI Hemorrhage

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2015-11-15

Study Completion:2025-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03065465

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Dennis M Jensen, MD

CONTACT

310-268-3569

djensen@mednet.ucla.edu

Kwanmanus N Suvanamas, BS

CONTACT

310-478-3711

ksuvanamas@mednet.ucla.edu

Principal Investigator

Dennis M Jensen, MD

PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Study Locations (Sites)

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073

United States

University of California, Los Angeles

Los Angeles, California, 90095

United States

Collaborators and Investigators

Sponsor: CURE Digestive Diseases Research Center

Dennis M Jensen, MD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-11-15

Study Completion Date2025-02-28

Study Record Updates

Study Start Date2015-11-15

Study Completion Date2025-02-28

Terms related to this study

Keywords Provided by Researchers

Upper GI hemorrhage
Stigmata of recent hemorrhage
Ulcers
Dieulafoy's lesions

Additional Relevant MeSH Terms

Upper Gastrointestinal Hemorrhage