GUT: Analysis of the difference in efficacy between the use of out-of-range clips (OTSC) and standard care for the prevention of rebleeding in large peptic ulcers (size ≥ 1.5 cm).

Acute upper gastrointestinal bleeding is a common and potentially life-threatening disease, non-variceal bleeding accounts for more than 80%~90% of the causes, of which gastroduodenal peptic ulcer bleeding is the main cause
.
Endoscopic hemostasis significantly improves outcomes in these patients, but 10% to 20% of patients continue bleeding or re-bleeding
despite acid suppression and endoscopic therapy.
Recurrent bleeding remains one of the most important predictors of
mortality.
Therefore, it is important to improve endoscopic hemostasis in high-risk populations to prevent rebleeding and thus death
.

Typically, endoscopic hemostasis is achieved by injection therapy, thermocoagulation, or mechanical therapy such as a tourniquet
.
Current international consensus guidelines recommend a combination of at least two hemostatic techniques for peptic ulcer bleeding
.
However, thermocoagulation and conventional hemostatic clips have limitations
.
For chronic ulcers with a fibrotic base, the application of the clip is sometimes difficult
.
A novel endoscopic clamping device, the Overrange Clamping Device (OTSC), however, data on primary hemostasis in peptic ulcers using OTSCs are lacking
.
To compare OTSC with standard endoscopic therapy for primary care in patients with peptic ulcer bleeding ≥ 1.
5 cm in size
.

This is a multicentre international randomized controlled trial
conducted between July 2017 and October 2020.
All patients with Forest IIa or more peptic ulcer ≥ 1.
5 cm were included in the study
.
The primary observation was clinical rebleeding
at 30 days.
Secondary endpoints included three-day all-cause mortality, need for blood transfusion, length of hospital stay and clinical success, and further interventions
.
This study required 100 patients to produce 80% efficacy to detect a difference
of -0.
15 at a significance level (alpha) of 0.
05 using a bilateral Z test (combined).

A total of 100 patients
were enrolled in this study.
Primary haemostasis
was successfully achieved in 46/50 (92%) and 48/50 (96%) in the OTSC and routine groups, respectively.
Among patients with successful initial hemostasis, 2/46 (4.
35%) patients in the OTSC group and 9/48 (18.
75%) in the conventional group experienced 30-day rebleeding (p=0.
03).

。 However, in intention-to-treat analysis, rebleeding within 30 days (5/50 (10%) OTSC vs 9/50 (18%) criteria, p=0.
23) or all-cause mortality (2/50 (4%) OTSC VS 4/50 (8%) criteria, p=0.
68; OR=2.
09, 95% CI 0.
37 to 11.
95).

There were also no differences
in transfusion requirements, length of hospital stay, admission to intensive care units, and further interventions.

This study confirms that routine use of OTSC as the primary haemostatic of major bleeding peptic ulcer is not associated with
a significant reduction in rebleeding at 30 days.

Original source:

Shannon Chan.
et al.
Use of over-the-scope clip (OTSC) versus standard therapy for the prevention of rebleeding in large peptic ulcers (size ≥1.
5 cm): an open-labelled, multicentre international randomised controlled trial.
GUT.
2022.