Standard Endoscopic Hemostasis Versus OVESCO Severe Non-variceal UGI Hemorrhage
NCT ID: NCT03065465
Last Updated: 2024-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
65 participants
INTERVENTIONAL
2015-11-15
2025-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Standard endoscopic treatment
For those assigned to the standard endoscopy group, endoscopic hemostasis is performed using usual CURE hemostasis therapy for the focal GI lesions: injection of dilute (e.g. 1: 20,000) epinephrine (in 1-2 cc aliquots in 4 quadrants next to the SRH) of active bleeding or adherent clots (prior to snaring them off); coaptive coagulation with multipolar electrocautery (MPEC) probe and/or standard through the endoscope hemoclips along the course of the underlying artery as detected by DEP. Hemostasis is performed until active bleeding stops and/or the SRH is obliterated. Residual blood flow after visually guided hemostasis is recorded, but not used as a guide for additional hemostasis in this study.
Standard endoscopic treatment
Standard therapy includes injection of dilute epinephrine, thermal coagulation with multipolar electrocautery (MPEC) probe, and/or hemoclips.
Over-the-scope hemoclipping device
For those assigned OTSC, prior to use of the OTSC in UGI lesions with active bleeding or adherent clots, dilute epinephrine (1: 20,000) is injected around the SRH in 1-2 cc aliquots and the clots are cold guillotined off, as previously described (2, 4, 17). As a brief additional description, after initial diagnosis and preparation of the lesion and SRH (as described for standard hemostasis), the therapeutic sized endoscope is removed and this or a diagnostic panendoscope will be affixed with the OTSC of appropriate size for the endoscope and the target lesion. The endoscope is re-introduced and passed to the bleeding site. The SRH is centered in the field of view and within the cap of the OTSC device. Using high suctioning and firm pressure to center the SRH, the lesion and SRH is captured into the cap and the OTSC is deployed by rotating the handle and thereby compressing the bleeding lesion and surrounding tissue with mechanical hemostasis.
Over-the-scope hemoclipping device
A endoscopic entrapment of tissue for control of bleeding or other applications.
Interventions
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Over-the-scope hemoclipping device
A endoscopic entrapment of tissue for control of bleeding or other applications.
Standard endoscopic treatment
Standard therapy includes injection of dilute epinephrine, thermal coagulation with multipolar electrocautery (MPEC) probe, and/or hemoclips.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
100 Years
ALL
Yes
Sponsors
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University of California, Los Angeles
OTHER
VA Greater Los Angeles Healthcare System
FED
CURE Digestive Diseases Research Center
OTHER
Responsible Party
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Principal Investigators
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Dennis M Jensen, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
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VA Greater Los Angeles Healthcare System
Los Angeles, California, United States
University of California, Los Angeles
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Camus M, Jensen DM, Kovacs TO, Jensen ME, Markovic D, Gornbein J. Independent risk factors of 30-day outcomes in 1264 patients with peptic ulcer bleeding in the USA: large ulcers do worse. Aliment Pharmacol Ther. 2016 May;43(10):1080-9. doi: 10.1111/apt.13591. Epub 2016 Mar 22.
Jensen DM, Kovacs TOG, Ohning GV, Ghassemi K, Machicado GA, Dulai GS, Sedarat A, Jutabha R, Gornbein J. Doppler Endoscopic Probe Monitoring of Blood Flow Improves Risk Stratification and Outcomes of Patients With Severe Nonvariceal Upper Gastrointestinal Hemorrhage. Gastroenterology. 2017 May;152(6):1310-1318.e1. doi: 10.1053/j.gastro.2017.01.042. Epub 2017 Feb 4.
Schmidt A, Golder S, Goetz M, Meining A, Lau J, von Delius S, Escher M, Hoffmann A, Wiest R, Messmann H, Kratt T, Walter B, Bettinger D, Caca K. Over-the-Scope Clips Are More Effective Than Standard Endoscopic Therapy for Patients With Recurrent Bleeding of Peptic Ulcers. Gastroenterology. 2018 Sep;155(3):674-686.e6. doi: 10.1053/j.gastro.2018.05.037. Epub 2018 May 24.
Nishiyama N, Mori H, Kobara H, Rafiq K, Fujihara S, Kobayashi M, Oryu M, Masaki T. Efficacy and safety of over-the-scope clip: including complications after endoscopic submucosal dissection. World J Gastroenterol. 2013 May 14;19(18):2752-60. doi: 10.3748/wjg.v19.i18.2752.
Monkemuller 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.
Kirschniak A, Kratt T, Stuker D, Braun A, Schurr MO, Konigsrainer 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. doi: 10.1016/j.gie.2007.01.034.
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.
Richter-Schrag HJ, Glatz T, Walker C, Fischer A, Thimme R. First-line endoscopic treatment with over-the-scope clips significantly improves the primary failure and rebleeding rates in high-risk gastrointestinal bleeding: A single-center experience with 100 cases. World J Gastroenterol. 2016 Nov 7;22(41):9162-9171. doi: 10.3748/wjg.v22.i41.9162.
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.
Golder 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.
Wedi E, Fischer A, Hochberger J, Jung C, Orkut S, Richter-Schrag HJ. Multicenter evaluation of first-line endoscopic treatment with the OTSC in acute non-variceal upper gastrointestinal bleeding and comparison with the Rockall cohort: the FLETRock study. Surg Endosc. 2018 Jan;32(1):307-314. doi: 10.1007/s00464-017-5678-7. Epub 2017 Jun 27.
Brandler J, Baruah A, Zeb M, Mehfooz A, Pophali P, Wong Kee Song L, AbuDayyeh B, Gostout C, Mara K, Dierkhising R, Buttar N. Efficacy of Over-the-Scope Clips in Management of High-Risk Gastrointestinal Bleeding. Clin Gastroenterol Hepatol. 2018 May;16(5):690-696.e1. doi: 10.1016/j.cgh.2017.07.020. Epub 2017 Jul 26.
Chandrasekar VT, Desai M, Aziz M, Patel HK, Gorrepati VS, Jegadeesan R, Rai T, Sathyamurthy A, Murino A, Hassan C, Repici A, Sharma P. Efficacy and safety of over-the-scope clips for gastrointestinal bleeding: a systematic review and meta-analysis. Endoscopy. 2019 Oct;51(10):941-949. doi: 10.1055/a-0994-4361. Epub 2019 Aug 30.
Jensen DM, Ohning GV, Kovacs TO, Ghassemi KA, Jutabha R, Dulai GS, Machicado GA. Doppler endoscopic probe as a guide to risk stratification and definitive hemostasis of peptic ulcer bleeding. Gastrointest Endosc. 2016 Jan;83(1):129-36. doi: 10.1016/j.gie.2015.07.012. Epub 2015 Aug 28.
Jensen DM, Kovacs TO, Jutabha R, Machicado GA, Gralnek IM, Savides TJ, Smith J, Jensen ME, Alofaituli G, Gornbein J. Randomized trial of medical or endoscopic therapy to prevent recurrent ulcer hemorrhage in patients with adherent clots. Gastroenterology. 2002 Aug;123(2):407-13. doi: 10.1053/gast.2002.34782.
Jensen DM, Kovacs T, Ghassemi KA, Kaneshiro M, Gornbein J. Randomized Controlled Trial of Over-the-Scope Clip as Initial Treatment of Severe Nonvariceal Upper Gastrointestinal Bleeding. Clin Gastroenterol Hepatol. 2021 Nov;19(11):2315-2323.e2. doi: 10.1016/j.cgh.2020.08.046. Epub 2020 Aug 20.
Other Identifiers
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OVESCO
Identifier Type: -
Identifier Source: org_study_id
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