Upper Gastrointestinal Hemorrhage Clinical Trial
Official title:
Randomized Controlled Trial (RCT) of Standard Endoscopic Hemostasis Compared to OVESCO for Severe Non-variceal UGI Hemorrhage
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.
Status | Recruiting |
Enrollment | 65 |
Est. completion date | February 28, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of California, Los Angeles | Los Angeles | California |
United States | VA Greater Los Angeles Healthcare System | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
CURE Digestive Diseases Research Center | University of California, Los Angeles, VA Greater Los Angeles Healthcare System |
United States,
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Gölder S, Neuhas L, Freuer D, Probst A, Ebigbo A, Braun G, Brueckner J, Stueckle J, Meier A, Messmann H. Over-the-scope clip in peptic ulcer bleeding: clinical success in primary and secondary treatment and factors associated with treatment failure. Endosc Int Open. 2019 Jun;7(6):E846-E854. doi: 10.1055/a-0898-3357. Epub 2019 Jun 13. — View Citation
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Kirschniak A, Kratt T, Stüker D, Braun A, Schurr MO, Königsrainer A. A new endoscopic over-the-scope clip system for treatment of lesions and bleeding in the GI tract: first clinical experiences. Gastrointest Endosc. 2007 Jul;66(1):162-7. — View Citation
Laine L, Jensen DM. Management of patients with ulcer bleeding. Am J Gastroenterol. 2012 Mar;107(3):345-60; quiz 361. doi: 10.1038/ajg.2011.480. Epub 2012 Feb 7. Review. — View Citation
Manta R, Galloro G, Mangiavillano B, Conigliaro R, Pasquale L, Arezzo A, Masci E, Bassotti G, Frazzoni M. Over-the-scope clip (OTSC) represents an effective endoscopic treatment for acute GI bleeding after failure of conventional techniques. Surg Endosc. 2013 Sep;27(9):3162-4. doi: 10.1007/s00464-013-2871-1. Epub 2013 Feb 23. — View Citation
Mönkemüller K, Peter S, Toshniwal J, Popa D, Zabielski M, Stahl RD, Ramesh J, Wilcox CM. Multipurpose use of the 'bear claw' (over-the-scope-clip system) to treat endoluminal gastrointestinal disorders. Dig Endosc. 2014 May;26(3):350-7. doi: 10.1111/den.12145. Epub 2013 Jul 16. — View Citation
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Wedi E, von Renteln D, Gonzalez S, Tkachenko O, Jung C, Orkut S, Roth V, Tumay S, Hochberger J. Use of the over-the-scope-clip (OTSC) in non-variceal upper gastrointestinal bleeding in patients with severe cardiovascular comorbidities: a retrospective study. Endosc Int Open. 2017 Sep;5(9):E875-E882. doi: 10.1055/s-0043-105496. Epub 2017 Sep 12. — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The rebleeding rate of non-variceal focal UGI lesions | The investigators will compare the rebleeding rate at 30 days follow up in the two treatment groups for all patients, ulcer patients only, and also patients with major stigmata of hemorrhage vs. lesser stigmata (oozing or flat spots). | Outcome measure will be assessed at 30 days after participants are enrolled | |
Secondary | Obliteration rates of underlying arterial blood flow (detected by Doppler endoscopic probe) | The investigators will use the Doppler endoscopic probe to measure the blood flow before and after the application of over-the-hemoclipping device and standard endoscopic hemostasis. | Outcome measure will be assessed at 30 days after the endoscopy treatment is completed | |
Secondary | Rates of surgery or IR, complications, and death | The investigators will compare the rates of surgery or IR, complications, transfusion, hospital stays, and death at 30 days for the two treatment groups. | Outcome measure will be assessed at 30 days after participants are enrolled |
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