Clinical trial NCT03551262: Over-the-scope Clip Versus Through-the-scope Clip for Endoscopic Hemostasis of High Risk Bleeding Peptic Ulcers
Official title: Over-the-scope Clip Versus Through-the-scope Clip for Endoscopic Hemostasis of High Risk Bleeding Peptic Ulcers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bleeding Peptic Ulcer
Lead sponsor: Azienda USL Modena
Sponsor class: OTHER
First posted: 2018-06-11
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, prospective, randomized, controlled
Primary purpose: TREATMENT

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

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.

Eligibility 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:

* patients who refused to participate at the trial
* pregnancy

Primary outcomes:
measure: successful haemostasis rate
timeFrame: during the EGDS
measure: 30-day rebleeding
timeFrame: up to 30 days
measure: overall clinical success
timeFrame: up to 30 days
Secondary outcomes:
measure: mortality
timeFrame: up to 30 days
measure: lenght of hospital stay
timeFrame: up to 30 days
measure: transfusion requirements
timeFrame: up to 30 days
measure: need for radiology
timeFrame: up to 30 days
measure: need for surgery
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Carpi
country: Italy
facility: Azienda USL Modena
state: Modena
Study officials:
affiliation: Digestive Endoscopy Unit, Northen Area, AUSL Modena (Italy)
name: Mauro Manno, MD
role: PRINCIPAL_INVESTIGATOR
References: