An interventional study of OTSC and TTS clip in Bleeding Peptic Ulcer, sponsored by Azienda USL Modena. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-06.
Sponsored by Azienda USL Modena · Not applicable, Interventional, and Treatment
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
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.
55 studies on the registry are indexed under Peptic Ulcer Hemorrhage; 6 are open to participants now.
This study's planned enrollment of 88 is below the median of 162 across 41 interventional studies indexed under Peptic Ulcer Hemorrhage.
Browse Peptic Ulcer Hemorrhage studies →Azienda USL Modena is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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 OTSC in bleeding peptic ulcer
Positioning of TTS clip in bleeding peptic ulcer
successful haemostasis rate
defined as the absence of bleeding upon at least one minute observation after the assigned endoscopic therapy
Time frame: 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
Time frame: up to 30 days
overall clinical success
defined as successful homeostasis rate without evidence of 30-day rebleeding
Time frame: up to 30 days
mortality
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
lenght of hospital stay
number of days during the hospital stay
Time frame: up to 30 days
transfusion requirements
number of transfunsions needed
Time frame: up to 30 days
need for radiology
further radiological procedure because of the previous endoscopic failure
Time frame: up to 30 days
need for surgery
further surgical procedure because of the previous endoscopic and radiological failures
Time frame: up to 30 days
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2018 (actual). Primary completion is estimated for Oct 2023, 60 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Azienda USL Modena