OTSCvsTTS: Over-the-scope Clip Versus Through-the-scope Clip for Endoscopic Hemostasis of High Risk Bleeding Peptic Ulcers
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: OTSC 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
Positioning of OTSC in bleeding peptic ulcer
|
| Active Comparator: TTS clip 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
Positioning of TTS clip in bleeding peptic ulcer
|
Outcome Measures
Primary Outcome Measures
- efficacy (rebleeding rate) [up to 30 days]
it will be measured as number of rebleeding episodes after primary hemostasis (i.e. hematemesis, suction of fresh blood from naso-gastric tube, instability of vital signs (as blood pressure and pulse, reduction of Hb more than 2 g/dl over a 24 hours period (early recurrence) or over 7 days (late recurrence) after initial stabilization..)
Secondary Outcome Measures
- mortality [up to 30 days]
number of patients dead with no more rebleeding episodes and number of patients dead with rebleeding episodes, despite the endoscopic treatment
- lenght of hospital stay [up to 30 days]
number of days during the hospital stay
- transfusion requirements [up to 30 days]
number of transfunsions needed
- need for radiology [up to 30 days]
further radiological procedure because of the previous endoscopic failure
- need for surgery [up to 30 days]
further surgical procedure because of the previous endoscopic and radiological failures
Eligibility Criteria
Criteria
Inclusion Criteria:
-
patients with suspected NVUGIB and subsequent endoscopic finding of peptic ulcer (Ia-IIb according to Forrest classification)
-
age ≥ 18 years
Exclusion Criteria:
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patients who refused to participate at the trial
-
pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Azienda USL Modena | Carpi | Modena | Italy | 41012 |
Sponsors and Collaborators
- Azienda USL Modena
Investigators
- Principal Investigator: Mauro Manno, MD, Digestive Endoscopy Unit, Northen Area, AUSL Modena (Italy)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 01-2017