Over-the-scope Clip Versus Through-the-scope Clip for Endoscopic Hemostasis of High Risk Bleeding Peptic Ulcers

Study Overview
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Brief Summary
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To compare in a multicenter, prospective, randomized, controlled trial the efficacy and safety of OTSC versus TTS clip for first-line hemostasis of high risk bleeding peptic ulcers

Detailed Description
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Despite major advances in the management of non-variceal upper gastrointestinal bleeding (NVUGIB) over the past decade including prevention of peptic ulcer bleeding, optimal use of endoscopic therapy and high-dose proton pump inhibition, this still carries considerable morbidity, mortality and health economic burden Of particular note are the re-bleeding rates, one of the most crucial predictive factors of morbidity and mortality that has not significantly improved as evident from longitudinal data in the past 15 years Although huge advances have been made in terms of therapeutic endoscopic devices available today, complete haemostasis of complicated lesions (i.e. severe bleeding from large vessels or fibrotic ulcer) still remains a challenge and can be difficult to achieve. In particular, traditional clipping devices often appear technically difficult to place and insufficient to provide adequate tissue compression to obliterate large bleeding vessels. The over-the-scope clip (OTSC) (Ovesco Endoscopy AG, Tubingen, Germany) system is a recently developed endoscopic device. In a preliminary experience, it has been successfully used in patients with severe bleeding or deep wall lesions, or perforations of the GI tract. Recent retrospectives studies have demonstrated the efficacy and safety of OTSC in patients undergoing emergency endoscopy for severe acute NVUGIB after failure of conventional techniques and as first-line To the best of the investigator's knowledge, no randomized clinical trial have been performed investigating the use of OTSC as first-line endoscopic treatment in patients with high-risk NVUGIB.

Official Title
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Over-the-scope Clip Versus Through-the-scope Clip for Endoscopic Hemostasis of High Risk Bleeding Peptic Ulcers

Conditions
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Bleeding Peptic Ulcer

Intervention / Treatment
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* Device: OTSC
* Device: TTS clip


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with suspected NVUGIB and subsequent endoscopic finding of peptic ulcer (Ia-IIb according to Forrest classification) age ≥ 18 years Exclusion Criteria: patients who refused to participate at the trial pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicenter, prospective, randomized, controlled
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OTSC<br>Use of OTSC to treat high-risk peptic ulcers (gastric and duodenal), i.e. Forrest Ia, Ib, IIa, IIb, in first-line endoscopic haemostatic treatment. | Device: OTSC<br>* Positioning of OTSC in bleeding peptic ulcer<br>|
| Active Comparator: TTS clip<br>Use of TTS clip to treat high-risk peptic ulcers (gastric and duodenal), i.e. Forrest Ia, Ib, IIa, IIb in first-line endoscopic haemostatic treatment | Device: TTS clip<br>* Positioning of TTS clip in bleeding peptic ulcer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| successful haemostasis rate | defined as the absence of bleeding upon at least one minute observation after the assigned endoscopic therapy | during the EGDS | 
| 30-day rebleeding | re-bleeding episodes (per patient), after the primary endoscopic hemostatic treatment, defined as one or more of the following signs: hematemesis presence of fresh blood in the nasogastric tube hemodynamic instability (pulse and blood pressure) reduction of Hb by more than 2 g/dL over a 24 h period (early recurrence) or over a 7 days period (late recurrence) after initial stabilization | up to 30 days | 
| overall clinical success | defined as successful homeostasis rate without evidence of 30-day rebleeding | up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | number of patients dead with no more rebleeding episodes and number of patients dead with rebleeding episodes, despite the endoscopic treatment | up to 30 days | 
| lenght of hospital stay | number of days during the hospital stay | up to 30 days | 
| transfusion requirements | number of transfunsions needed | up to 30 days | 
| need for radiology | further radiological procedure because of the previous endoscopic failure | up to 30 days | 
| need for surgery | further surgical procedure because of the previous endoscopic and radiological failures | up to 30 days |