Over-the-scope Clip Versus Through-the-scope Clip for Endoscopic Hemostasis of High Risk Bleeding Peptic Ulcers (OTSCvsTTS)
Primary Purpose
Bleeding Peptic Ulcer
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
OTSC
TTS clip
Sponsored by
About this trial
This is an interventional treatment trial for Bleeding Peptic Ulcer
Eligibility Criteria
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
Sites / Locations
- Azienda USL ModenaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
OTSC
TTS clip
Arm 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.
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
Outcomes
Primary Outcome Measures
successful haemostasis rate
defined as the absence of bleeding upon at least one minute observation after the assigned endoscopic therapy
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
overall clinical success
defined as successful homeostasis rate without evidence of 30-day rebleeding
Secondary Outcome Measures
mortality
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
number of days during the hospital stay
transfusion requirements
number of transfunsions needed
need for radiology
further radiological procedure because of the previous endoscopic failure
need for surgery
further surgical procedure because of the previous endoscopic and radiological failures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03551262
Brief Title
Over-the-scope Clip Versus Through-the-scope Clip for Endoscopic Hemostasis of High Risk Bleeding Peptic Ulcers
Acronym
OTSCvsTTS
Official Title
Over-the-scope Clip Versus Through-the-scope Clip for Endoscopic Hemostasis of High Risk Bleeding Peptic Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2018 (Actual)
Primary Completion Date
October 26, 2023 (Anticipated)
Study Completion Date
October 26, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda USL Modena
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding Peptic Ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multicenter, prospective, randomized, controlled
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
OTSC
Arm Type
Experimental
Arm 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.
Arm Title
TTS clip
Arm Type
Active Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
OTSC
Intervention Description
Positioning of OTSC in bleeding peptic ulcer
Intervention Type
Device
Intervention Name(s)
TTS clip
Intervention Description
Positioning of TTS clip in bleeding peptic ulcer
Primary Outcome Measure Information:
Title
successful haemostasis rate
Description
defined as the absence of bleeding upon at least one minute observation after the assigned endoscopic therapy
Time Frame
during the EGDS
Title
30-day rebleeding
Description
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
Time Frame
up to 30 days
Title
overall clinical success
Description
defined as successful homeostasis rate without evidence of 30-day rebleeding
Time Frame
up to 30 days
Secondary Outcome Measure Information:
Title
mortality
Description
number of patients dead with no more rebleeding episodes and number of patients dead with rebleeding episodes, despite the endoscopic treatment
Time Frame
up to 30 days
Title
lenght of hospital stay
Description
number of days during the hospital stay
Time Frame
up to 30 days
Title
transfusion requirements
Description
number of transfunsions needed
Time Frame
up to 30 days
Title
need for radiology
Description
further radiological procedure because of the previous endoscopic failure
Time Frame
up to 30 days
Title
need for surgery
Description
further surgical procedure because of the previous endoscopic and radiological failures
Time Frame
up to 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mauro Manno, MD
Phone
+39059659250
Email
m.manno@ausl.mo.it
First Name & Middle Initial & Last Name or Official Title & Degree
Paola Soriani
Phone
+39059659250
Email
p.soriani@ausl.mo.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauro Manno, MD
Organizational Affiliation
Digestive Endoscopy Unit, Northen Area, AUSL Modena (Italy)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda USL Modena
City
Carpi
State/Province
Modena
ZIP/Postal Code
41012
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paola Soriani, MD
Phone
00039059659250
Email
p.soriani@ausl.mo.it
12. IPD Sharing Statement
Plan to Share IPD
No
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Over-the-scope Clip Versus Through-the-scope Clip for Endoscopic Hemostasis of High Risk Bleeding Peptic Ulcers
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