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

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

Study Overview

• Status: Recruiting
• Conditions: Bleeding Peptic Ulcer
• Intervention / Treatment: Device: OTSC; Device: TTS clip

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 Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mauro Manno, MD; Phone Number: +39059659250; Email: m.manno@ausl.mo.it
• Study Contact Backup: Name: Paola Soriani; Phone Number: +39059659250; Email: p.soriani@ausl.mo.it

Study Locations

• Italy
  • Modena
    • Carpi, Modena, Italy, 41012
      • Recruiting
      • Azienda USL Modena
      • Contact: Paola Soriani, MD; Phone Number: 00039059659250; Email: p.soriani@ausl.mo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: OTSC; Positioning of OTSC in bleeding peptic ulcer
Active Comparator: 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	Device: TTS clip; Positioning of TTS clip in bleeding peptic ulcer

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Azienda USL Modena
• Investigators: Principal Investigator: Mauro Manno, MD, Digestive Endoscopy Unit, Northen Area, AUSL Modena (Italy)

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2018
• Primary Completion (Anticipated): October 26, 2023
• Study Completion (Anticipated): October 26, 2023

Study Registration Dates

• First Submitted: October 13, 2017
• First Submitted That Met QC Criteria: June 8, 2018
• First Posted (Actual): June 11, 2018

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Duodenal Diseases; Gastrointestinal Hemorrhage; Ulcer; Hemorrhage; Peptic Ulcer; Peptic Ulcer Hemorrhage
• Other Study ID Numbers: 01-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No