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

Bleeding Peptic Ulcer Clinical Trial

— OTSCvsTTS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03551262
• Other study ID #: 01-2017
• Status: Recruiting
• Phase: N/A
• Start date: October 26, 2018
• Est. completion date: October 26, 2023

Study information

• Verified date: July 2022
• Source: Azienda USL Modena
• Contact: Mauro Manno, MD
• Phone: +39059659250
• Email: m.manno[@]ausl.mo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: October 26, 2023
• Est. primary completion date: October 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bleeding Peptic Ulcer
• Hemorrhage
• Peptic Ulcer
• Peptic Ulcer Hemorrhage
• Ulcer

Intervention

Device:
• OTSC
Positioning of OTSC in bleeding peptic ulcer
• TTS clip
Positioning of TTS clip in bleeding peptic ulcer

Locations

Country	Name	City	State
Italy	Azienda USL Modena	Carpi	Modena

Sponsors (1)

Lead Sponsor	Collaborator
Azienda USL Modena

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	successful haemostasis rate	defined as the absence of bleeding upon at least one minute observation after the assigned endoscopic therapy	during the EGDS
Primary	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
Primary	overall clinical success	defined as successful homeostasis rate without evidence of 30-day rebleeding	up to 30 days
Secondary	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
Secondary	lenght of hospital stay	number of days during the hospital stay	up to 30 days
Secondary	transfusion requirements	number of transfunsions needed	up to 30 days
Secondary	need for radiology	further radiological procedure because of the previous endoscopic failure	up to 30 days
Secondary	need for surgery	further surgical procedure because of the previous endoscopic and radiological failures	up to 30 days