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

NCT03551262 | Unknown

• 1 other identifier: 01-2017
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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

Conditions

Bleeding Peptic Ulcer

Outcome Measures

Primary Outcomes (3)

• successful haemostasis rate

  defined as the absence of bleeding upon at least one minute observation after the assigned endoscopic therapy

  during the EGDS

• 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

• overall clinical success

  defined as successful homeostasis rate without evidence of 30-day rebleeding

  up to 30 days

Secondary Outcomes (5)

• mortality

  up to 30 days

• lenght of hospital stay

  up to 30 days

• transfusion requirements

  up to 30 days

• need for radiology

  up to 30 days

• need for surgery

  up to 30 days

Study Arms (2)

OTSC

EXPERIMENTAL

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

TTS clip

ACTIVE COMPARATOR

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

Interventions

OTSC DEVICE

Positioning of OTSC in bleeding peptic ulcer

OTSC

TTS clip DEVICE

Positioning of TTS clip in bleeding peptic ulcer

TTS clip

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with suspected NVUGIB and subsequent endoscopic finding of peptic ulcer (Ia-IIb according to Forrest classification)
• age ≥ 18 years

You may not qualify if:

• patients who refused to participate at the trial
• pregnancy

Sponsors & Collaborators

• Azienda USL Modena: lead

Study Sites (1)

Azienda USL Modena

Carpi, Modena, 41012, Italy

RECRUITING

MeSH Terms

Conditions

Peptic Ulcer Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Hemorrhage; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mauro Manno, MD

  Digestive Endoscopy Unit, Northen Area, AUSL Modena (Italy)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mauro Manno, MD

CONTACT

+39059659250; m.manno@ausl.mo.it

Paola Soriani

CONTACT

+39059659250; p.soriani@ausl.mo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Digestive Endoscopy Unit, Principal Investigator

Model Details: Multicenter, prospective, randomized, controlled

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: June 11, 2018
• Study Start: October 26, 2018
• Primary Completion: October 26, 2023
• Study Completion: October 26, 2023
• Last Updated: May 6, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)