Back to resultsStandard Endoscopic Hemostasis Versus OVESCO Severe Non-variceal UGI Hemorrhage
Primary Purpose
Upper Gastrointestinal Hemorrhage
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Over-the-scope hemoclipping device
Standard endoscopic treatment
Sponsored by
About this trial
This is an interventional treatment trial for Upper Gastrointestinal Hemorrhage focused on measuring Upper GI hemorrhage, Stigmata of recent hemorrhage, Ulcers, Dieulafoy's lesions
Eligibility Criteria
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.
Sites / Locations
- VA Greater Los Angeles Healthcare SystemRecruiting
- University of California, Los AngelesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Standard endoscopic treatment
Over-the-scope hemoclipping device
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03065465
First Posted
November 29, 2016
Last Updated
March 21, 2022
Sponsor
CURE Digestive Diseases Research Center
Collaborators
University of California, Los Angeles, VA Greater Los Angeles Healthcare System
1. Study Identification
Unique Protocol Identification Number
NCT03065465
Brief Title
Standard Endoscopic Hemostasis Versus OVESCO Severe Non-variceal UGI Hemorrhage
Official Title
Randomized Controlled Trial (RCT) of Standard Endoscopic Hemostasis Compared to OVESCO for Severe Non-variceal UGI Hemorrhage
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2015 (undefined)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
February 28, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CURE Digestive Diseases Research Center
Collaborators
University of California, Los Angeles, VA Greater Los Angeles Healthcare System
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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, 25% - 30% of high risk patients with UGIB from ulcers or other non-variceal UGI lesions (NVUGI) had recurrent bleeding in a recent RCT and cohort studies by our group. Potential risk factors for NVUGI rebleeding were large ulcers (≥ 15 mm), fibrotic bases, Dieulafoy's lesions, anastomotic ulcers, coagulopathies, cirrhosis, other severe co-morbidities and residual arterial blood flow under stigmata of recent hemorrhage (SRH) after endoscopic treatment. Such patients with 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 underlying arteries than standard hemoclips and potentially can improve endoscopic hemostasis of such bleeding lesions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Gastrointestinal Hemorrhage
Keywords
Upper GI hemorrhage, Stigmata of recent hemorrhage, Ulcers, Dieulafoy's lesions
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
65 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard endoscopic treatment
Arm Type
Other
Arm Description
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.
Arm Title
Over-the-scope hemoclipping device
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Over-the-scope hemoclipping device
Other Intervention Name(s)
OTSC clip
Intervention Description
A endoscopic entrapment of tissue for control of bleeding or other applications.
Intervention Type
Other
Intervention Name(s)
Standard endoscopic treatment
Intervention Description
Standard therapy includes injection of dilute epinephrine, thermal coagulation with multipolar electrocautery (MPEC) probe, and/or hemoclips.
Primary Outcome Measure Information:
Title
The rebleeding rate of non-variceal focal UGI lesions
Description
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).
Time Frame
Outcome measure will be assessed at 30 days after participants are enrolled
Secondary Outcome Measure Information:
Title
Obliteration rates of underlying arterial blood flow (detected by Doppler endoscopic probe)
Description
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.
Time Frame
Outcome measure will be assessed at 30 days after the endoscopy treatment is completed
Title
Rates of surgery or IR, complications, and death
Description
The investigators will compare the rates of surgery or IR, complications, transfusion, hospital stays, and death at 30 days for the two treatment groups.
Time Frame
Outcome measure will be assessed at 30 days after participants are enrolled
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dennis M Jensen, MD
Phone
310-268-3569
Email
djensen@mednet.ucla.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kwanmanus N Suvanamas, BS
Phone
310-478-3711
Ext
43324
Email
ksuvanamas@mednet.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis M Jensen, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare System
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dennis M Jensen, MD
Phone
310-268-3569
Email
dennis.jensen@va.gov
First Name & Middle Initial & Last Name & Degree
Kwanmanus N Suvanamas, BS
Phone
310-478-3711
Ext
43324
Email
kwanmanus.suvanamas@va.gov
First Name & Middle Initial & Last Name & Degree
Dennis M Jensen, MD
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dennis M Jensen, MD
Phone
310-268-3569
Email
djensen@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Kwanmanus N Suvanamas, BS
Phone
310-478-3711
Ext
43324
Email
ksuvanamas@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Dennis M Jensen, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Standard Endoscopic Hemostasis Versus OVESCO Severe Non-variceal UGI Hemorrhage
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