Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OTSC | Experimental | 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. |
|
| TTS clip | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OTSC | Device | Positioning of OTSC in bleeding peptic ulcer |
| |
| TTS clip |
| 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:
| up to 30 days |
| overall clinical success | defined as successful homeostasis rate without evidence of 30-day rebleeding | up to 30 days |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mauro Manno, MD | Contact | +39059659250 | m.manno@ausl.mo.it | |
| Paola Soriani | Contact | +39059659250 | p.soriani@ausl.mo.it |
| Name | Affiliation | Role |
|---|---|---|
| Mauro Manno, MD | Digestive Endoscopy Unit, Northen Area, AUSL Modena (Italy) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda USL Modena | Recruiting | Carpi | Modena | 41012 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010438 | Peptic Ulcer Hemorrhage |
| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
Not provided
Not provided
Multicenter, prospective, randomized, controlled
Not provided
Not provided
Not provided
Not provided
| Device |
Positioning of TTS clip in bleeding peptic ulcer |
|
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 |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |