Randomized Controlled Trial (RCT) of Standard Endoscopic Hemostasis Compared to OVESCO for Severe Non-variceal UGI Hemorrhage

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: t
View:

• 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.

Locations
United States
California
University of California, Los Angeles
RECRUITING
Los Angeles
VA Greater Los Angeles Healthcare System
RECRUITING
Los Angeles
Contact Information
Primary
Dennis M Jensen, MD
djensen@mednet.ucla.edu
310-268-3569
Backup
Kwanmanus N Suvanamas, BS
ksuvanamas@mednet.ucla.edu
310-478-3711
Time Frame
Start Date: 2015-11-15
Estimated Completion Date: 2025-02-28
Participants
Target number of participants: 65
Treatments
Other: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: CURE Digestive Diseases Research Center
Collaborators: VA Greater Los Angeles Healthcare System, University of California, Los Angeles

This content was sourced from clinicaltrials.gov