The Use of Over-the-scope-clip for Prevention of Rebleeding in High Risk Peptic Ulcers

Ulcer Bleeding Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03160911
• Other study ID #: 2016.711-T
• Status: Completed
• Phase: N/A
• Start date: March 16, 2018
• Est. completion date: February 28, 2022

Study information

• Verified date: July 2022
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 28, 2022
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Peptic Ulcer
• Ulcer
• Ulcer Bleeding
• Upper Gastrointestinal Tract Bleeding

Intervention

Device:
• Over-the-scope clip (OTSC)
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. Endoscopic haemostasis would be achieved with the use of this device and/or injection of adrenaline
• Conventional Endoscopic Haemostasis
This includes the use of heater probe, endoscopic clipping and injection of adrenaline for endoscopic haemostasis

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of cases that develop clinical rebleeding	Clinical rebleeding is defined as fresh hematemesis, fresh melena or hematochezia and signs of hypovolemic shock (systolic blood pressure of <90mmHg and pulse rate >110 per minute) and/or a drop in hemoglobin of > 2 g/dl per 24 hours despite adequate transfusion. Rebleeding would be confirmed by an immediate endoscopy showing fresh blood in stomach or active bleeding from a previously seen ulcer. A clinical rebleeding will be independently reviewed by an adjudication panel.	Within 30 days of therapy
Secondary	Number of cases that died	Death from all causes within 30 days of therapy	within 30 days of therapy
Secondary	Number of units of blood transfusion required in each patient	Number of units of blood transfusion required in each patient within 30 days of therapy	within 30 days of therapy
Secondary	Hospital stay	Hospital stay for the episode of bleeding	up to one year
Secondary	Number of cases with failure of achieving primary haemostasis	The number of cases with failure of achieving primary haemostasis. Failure of primary haemostasis is defined by the inability to achieve haemostasis during the index endoscopy.	Within 30 days of therapy
Secondary	The number of cases requiring further interventions such as repeat endoscopy, surgery or transarterial embolization	The number of cases requiring further interventions such as repeat endoscopy, surgery or transarterial embolization	Within 30 days of therapy
Secondary	Hospital costs	The total direct costs required for the hospital admission for the episode of bleeding measured in Hong Kong dollars	Up to one year