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

Azienda USL Modena

Status: Enrolling

Conditions: Bleeding Peptic Ulcer

Treatments: Device: OTSC; Device: TTS clip

Study type: Interventional

Funder types: Other

Identifiers

NCT03551262

01-2017

Details and patient eligibility

About

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

Full 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.

Enrollment: 88 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

OTSC

Experimental group

Description:

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.

Treatment:

Device: OTSC

TTS clip

Active Comparator group

Description:

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

Treatment:

Device: TTS clip