Prospective Study Using a Combination of Epinephrine Injection Therapy and Either an Endoscopic Hemoclip (Resolution Clip) or a Heater Probe for Peptic Ulcer Disease.
The study includes three parts: screening, procedure and follow up visit. During the screening, the subjects will be examined as candidates for the study. The subject[Right Quote]s medical history and some descriptive information (birth date, race, and sex) will be recorded. The resting pulse and blood pressure will be recorded. They will have blood test to check hemoglobin level. These procedures may be done even if the subjects do not participate in this research. The subjects will have urine pregnancy test if they are a female able to have children. The decision to have the procedure is independent of participating in this study. It usually takes about 30 minutes to complete the procedure. The pregnant women are excluded from the study. It is not known whether Combination of Epinephrine Injection Therapy and an Endoscopic Hemoclip may harm an emryo or fetus or an infant who is breast feeding. It is not known whether Combination of Epinephrine Injection Therapy and an Endoscopic Hemoclip may lead to birth defects.
There are no study visits after the procedure. But the subjects will be asked to have a follow-up visit with the study doctor as part of their standard of care. The total length of participation in this study will include hospital stay. At 30 days the study personnel will check for re-bleeding events and mortality using the electronic medical record. No visit at 30 days will be required.
Subjects will sign the consent form prior to screening. Subjects who fulfill the criteria will be offered participation. Endoscopy will be performed within 12 hours of identification of active gastrointestinal hemorrhage for hospitalized patients or presentation to the emergency department for newly admitted patients. Computer generated randomization will be used for treatment assignment. An actively oozing or bleeding lesion or a visible vessel will be treated with combination therapy. Adherent clots will be lavaged and treated with epinephrine. The clot will be removed. Mixture of sterile saline and epinephrine will be injected in four quadrants and into the bleeding site. Depending on the assignments, then study subject will receive either Hemoclip or Heater Probe into the bleeding site until the bleeding is arrested. Epinephrine is a medication with tightens the blood vessels. Hemoclip is a small device to stop the bleeding by clipping the bleeding spot. The heater probe is a hollow aluminum cylinder with an inner coil that transfers heat to tissue when positioned. Both devices are used in routine clinic. The subjects do not have to participate in this research to receive care for their medical problem. The study doctors could help the subjects to decide whether to participate in the research or receive the standard care that is currently available for their medical problem.Hemoclip is a FDA approved devise, and has been on the market for a while. It is used in the clinic as one of the routine treatments. All study doctors are faculties at UTSouthwestern Medical Center at Dallas, they are trained to provide best care and treatment for GI bleeding patients.
All patients with GI bleed who present with:
-vomiting or defecating fresh or old blood within the last seven days
-the presence of gross blood on nasogastric tube aspirate
-black or tarry stools on digital rectal examination.