Clinical trial NCT03160911: The Use of Over-the-scope-clip for Prevention of Rebleeding in High Risk Peptic Ulcers
Official title: The Use of Over-the-scope-clip (OTSC) Versus Standard Therapy for the Prevention of Rebleeding in High Risk Peptic Ulcers: a Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcer Bleeding
Upper Gastrointestinal Tract Bleeding
Keywords: Over-the-scope clip
endoscopic haemostasis
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two separate interventional arms. In case of treatment failure, the two groups are allowed to crossover to the other group.
Primary purpose: TREATMENT

Brief summary: Non-variceal acute gastrointestinal bleeding is a common and potentially life-threatening problem. The conventional treatment of this condition is for esophagogastroduodenoscopy (OGD) for haemostasis. Treatment methods include heater probe, clipping and injection of adrenaline. Recently, a new device called the Over-the-scope clip (OTSC) has been device to treat perforations and bleeding in the gastrointestinal tract. Therefore, the aim of the study is to compare between the treatment outcomes between OTSC and conventional endoscopic haemostatic methods in ulcers that are of high risk for rebleeding.

Detailed description: Acute upper gastrointestinal bleeding is a common and potentially life-threatening condition. Non-variceal bleeding accounts for more than 80-90% of the cause with gastroduodenal peptic ulcer being the major cause. Endoscopic haemostasis has significantly improved the outcome of these patients. Recurrent bleeding remains one of the most important predictors of mortality. Previous studies have identified ulcers that are high risk for rebleeding.

Conventionally, endoscopic haemostasis is achieved by injection therapy, thermocoagulation or mechanical therapy such as haemostatic clips. However, there are limitations to thermo-coagulation and conventional haemostatic clips. Over the past few years, a novel endoscopic clipping device, the Over-The-Scope Clip (OTSC; Oversco Endoscopy AG, Tübingen, Germany) has become available. The device provides a robust and strong tissue apposition. The system was developed to close perforations and treat bleeding in the gastrointestinal tract. In chronic ulcers, an anchor device can be used to pull the ulcer base toward the aspiration cap to facilitate accurate clip application. With a larger jaw width and greater strength, the OTSC is expected to have superior haemostatic properties when compared to hemo-clips. Case series have been published on the clinical experience of OTSC on gastrointestinal bleeding with promising results.

Therefore, in this randomised controlled trial, we aim to compare the efficacy of the OTSC to standard endoscopic therapy in primary treatment of patients with peptic ulcer bleeding that are of high-risk for rebleeding. The hypothesis is that the use OTSC can significantly decrease the rebleeding rate in this group of patients.

Eligibility criteria: Inclusion Criteria:

1. Actively bleeding peptic ulcers (Forrest Ia, Ib), ulcers with non-bleeding visible vessel or Forrest IIa ulcer (defined as protuberant discoloration, or ulcers with an initial clot and upon irrigation shows a vessel) AND
2. Ulcer size ≥ 1.5 cm as determined by an opened biopsy forceps;

Exclusion Criteria:

1. Patients aged below 18
2. Peptic ulcer with concomitant perforation
3. Tumor bleeding
4. Variceal bleeding
5. Patients who are pregnant or lactating
6. Moribund patients or patients with terminal malignancy or end-stage non-malignant conditions, in whom life expectancy is less than 30 days

Primary outcomes:
measure: The number of cases that develop clinical rebleeding
timeFrame: Within 30 days of therapy
Secondary outcomes:
measure: Number of cases that died
timeFrame: within 30 days of therapy
measure: Number of units of blood transfusion required in each patient
timeFrame: within 30 days of therapy
measure: Hospital stay
timeFrame: up to one year
measure: Number of cases with failure of achieving primary haemostasis
timeFrame: Within 30 days of therapy
measure: The number of cases requiring further interventions such as repeat endoscopy, surgery or transarterial embolization
timeFrame: Within 30 days of therapy
measure: Hospital costs
timeFrame: Up to one year
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Shannon M Chan, MBCHB, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chan S, Pittayanon R, Wang HP, Chen JH, Teoh AY, Kuo YT, Tang RS, Yip HC, Ng SKK, Wong S, Mak JWY, Chan H, Lau L, Lui RN, Wong M, Rerknimitr R, Ng EK, Chiu PWY. 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. 2023 Apr;72(4):638-643. doi: 10.1136/gutjnl-2022-327007. Epub 2022 Oct 28.