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Standard Endoscopic Hemostasis Versus OVESCO Severe Non-variceal UGI Hemorrhage

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ClinicalTrials.gov Identifier: NCT03065465
Recruitment Status : Recruiting
First Posted : February 28, 2017
Last Update Posted : July 6, 2018
Sponsor:
Collaborators:
University of California, Los Angeles
VA Greater Los Angeles Healthcare System
Information provided by (Responsible Party):
CURE Digestive Diseases Research Center

Brief Summary:
The primary specific aim is to perform a randomized controlled trial (RCT) to compare the rebleeding rates and other clinical outcomes of severe, refractory or recurrent non-variceal upper GI hemorrhage (NVUGIH) with a new over-the-scope hemoclipping device (OVESCO) versus standard endoscopic hemostasis.

Condition or disease Intervention/treatment Phase
Upper Gastrointestinal Hemorrhage Device: Over-the-scope hemoclipping device Other: Standard endoscopic treatment Not Applicable

Detailed Description:
Upper GI Hemorrhage (UGIH) causes significant morbidity and mortality, although endoscopic hemostasis has revolutionized management of these patients. Despite standard endoscopic treatment and high dose proton pump infusions, 27% of patients in referral hospitals with upper gastrointestinal bleeding (UGIB) from ulcers or other non-variceal UGI lesions (NVUGI) have refractory or recurrent bleeding in a recent RCT by our group. Potential risk factors for NVUGI bleeding lesions were large ulcers (≥ 15 mm), fibrotic base, Dieulafoy's lesions, anastomotic ulcers, coagulopathies, cirrhosis, severe co-morbidities, and residual arterial blood flow under stigmata after endoscopic hemostasis. Such patients with severe rebleeding after standard endoscopic hemostasis usually required angiography (by interventional radiologists-IR) or surgery for definitive hemostasis. A new, large, FDA approved, over-the-scope hemoclipping device (OTSC® System OVESCO Endoscopy, Tübingen, Germany) can capture larger amounts of tissue and larger underlying arteries than standard hemoclips and potentially could improve endoscopic hemostasis of such bleeding lesions.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial (RCT) of Standard Endoscopic Hemostasis Compared to OVESCO for Severe Non-variceal UGI Hemorrhage
Study Start Date : November 2015
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Standard endoscopic treatment
For those assigned to the standard endoscopy group, endoscopic hemostasis will be performed using usual Center for Ulcer Research and Education (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 stigmata of recent hemorrhage - SRH), coaptive coagulation with multipolar electrocautery (MPEC) probe, and/or standard through the endoscope hemoclips along the course of the underlying artery as detected by Doppler endoscopic probe (DEP). Hemostasis will be performed until active bleeding stops and/or the SRH is obliterated.
Other: Standard endoscopic treatment
Standard therapy includes injection of dilute epinephrine, thermal coagulation with multipolar electrocautery (MPEC) probe, and/or hemoclips.

Experimental: Over-the-scope hemoclipping device
For those assigned OTSC, the device will be used according to manufacturer instructions. Once the endoscopic diagnosis is made, the endoscope will be removed and affixed with the OTSC of appropriate size for the endoscope and the lesion in question. The endoscope will be re-introduced to the bleeding site. The SRH will be centered in the field of view and within the cap of the OTSC deployment device. The lesion and SRH will be captured into the cap and the OTSC will be deployed by rotating the handle and thereby compressing the bleeding lesion and surrounding tissue for mechanical hemostasis. If initial deployment is unsuccessful due to technical factors or if hemostasis is not achieved, a second deployment will be allowed.
Device: Over-the-scope hemoclipping device
A endoscopic entrapment of tissue for control of bleeding or other applications.
Other Name: OVESCO clip




Primary Outcome Measures :
  1. The rebleeding rate of non-variceal focal UGI lesions [ Time Frame: Outcome measure will be assessed at 30 days after participants are enrolled ]
    The investigators will compare the rebleeding rate at 30 days follow up in the two treatment groups.


Secondary Outcome Measures :
  1. Obliteration rates of underlying arterial blood flow (detected by Doppler endoscopic probe) [ Time Frame: Outcome measure will be assessed at 30 days after the endoscopy treatment is completed ]
    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.

  2. Rates of surgery or IR, complications, cross-over to other endoscopic treatment and death [ Time Frame: Outcome measure will be assessed at 30 days after participants are enrolled ]
    The investigators will compare the rates of surgery or IR, complications, and death at 30 days for the two treatment groups.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Written informed consent from the patient or a surrogate.
  • Clinical evidence of severe UGIB.
  • Presence of a benign appearing peptic ulcer, post-Endoscopic mucosal resection (EMR) ulcer, anastomotic ulcer, Dieulafoy's lesion, or UGI post-polypectomy induced ulcer with some SRH on endoscopy.
  • Severe bleeding, refractory bleeding, or recurrent 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 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, 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, peritonitis, or unstable cardiopulmonary status).
  • Stricture of the esophagus or pylorus that can not be dilated or precludes passage of a 12 mm diameter endoscope and/or GI endoscope with the large hemoclipping device-Ovesco.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03065465


Contacts
Contact: Dennis M Jensen, MD 310-268-3569 djensen@mednet.ucla.edu
Contact: Kwanmanus N Suvanamas, BS 310-478-3711 ext 43324 ksuvanamas@mednet.ucla.edu

Locations
United States, California
VA Greater Los Angeles Healthcare System Recruiting
Los Angeles, California, United States, 90073
Contact: Dennis M Jensen, MD    310-268-3569    dennis.jensen@va.gov   
Contact: Kwanmanus N Suvanamas, BS    310-478-3711 ext 43324    kwanmanus.suvanamas@va.gov   
Principal Investigator: Dennis M Jensen, MD         
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Dennis M Jensen, MD    310-268-3569    djensen@mednet.ucla.edu   
Contact: Kwanmanus N Suvanamas, BS    310-478-3711 ext 43324    ksuvanamas@mednet.ucla.edu   
Principal Investigator: Dennis M Jensen, MD         
Sponsors and Collaborators
CURE Digestive Diseases Research Center
University of California, Los Angeles
VA Greater Los Angeles Healthcare System
Investigators
Principal Investigator: Dennis M Jensen, MD University of California, Los Angeles

Publications:

Responsible Party: CURE Digestive Diseases Research Center
ClinicalTrials.gov Identifier: NCT03065465     History of Changes
Other Study ID Numbers: OVESCO
First Posted: February 28, 2017    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by CURE Digestive Diseases Research Center:
Upper GI hemorrhage
Stigmata of recent hemorrhage
Diverticular Hemorrhage
Ulcers

Additional relevant MeSH terms:
Hemorrhage
Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Hemostatics
Coagulants