NCT03065465

Standard Endoscopic Hemostasis Versus OVESCO Severe Non-variceal UGI Hemorrhage

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: CURE Digestive Diseases Research Center · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

Conditions

• Upper Gastrointestinal Hemorrhage

Interventions

Type	Name	Description
DEVICE	Over-the-scope hemoclipping device	A endoscopic entrapment of tissue for control of bleeding or other applications.
OTHER	Standard endoscopic treatment	Standard therapy includes injection of dilute epinephrine, thermal coagulation with multipolar electrocautery (MPEC) probe, and/or hemoclips.

Timeline

• Start date: 2015-11-15
• Primary completion: 2024-12-24
• Completion: 2025-02-28
• First posted: 2017-02-28
• Last updated: 2024-08-27

Locations

2 sites across 1 country: United States