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

Not Applicable

• Conditions: Bleeding Peptic Ulcer
• Interventions: Device: TTS clip; Device: OTSC

• Registration Number: NCT03551262
• Lead Sponsor: Azienda USL Modena

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.

Study Timeline

• Study First Submitted: 2017-10-13
• Study First Submitted QC: 2018-06-08
• Study First Posted: 2018-06-11
• Study Start: 2018-10-26
• Status Verified: 2022-07
• Last Update Submitted: 2023-05-04
• Last Update Posted: 2023-05-06
• Primary Completion: 2023-10-26
• Study Completion: 2023-10-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TTS clip	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
OTSC	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.

Primary Outcome Measures

Name	Time	Method
overall clinical success	up to 30 days	defined as successful homeostasis rate without evidence of 30-day rebleeding
successful haemostasis rate	during the EGDS	defined as the absence of bleeding upon at least one minute observation after the assigned endoscopic therapy
30-day rebleeding	up to 30 days	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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Azienda USL Modena; 🇮🇹 Carpi, Modena, Italy