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

Not Applicable

Completed

• Conditions: Ulcer Bleeding; Upper Gastrointestinal Tract Bleeding
• Interventions: Device: Conventional Endoscopic Haemostasis; Device: Over-the-scope clip (OTSC)

• Registration Number: NCT03160911
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study First Submitted: 2017-05-14
• Study First Submitted QC: 2017-05-17
• Study First Posted: 2017-05-19
• Study Start: 2018-03-16
• Primary Completion: 2021-08-31
• Study Completion: 2022-02-28
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-07
• Last Update Posted: 2022-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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;

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional endoscopic haemostasis	Conventional Endoscopic Haemostasis	The patient would receive an esophagogastroduodenoscope to identify the bleeding source. Haemostasis will be performed in the conventional way, either using heater probe, endoscopic clips and/or injection of adrenaline
Over-the-scope clip	Over-the-scope clip (OTSC)	The patient would receive an esophagogastroduodenoscope to identify the bleeding source. The endoscopist can decided whether to pre inject the ulcer with adrenaline. Then the OTSC is used for haemostasis.

Primary Outcome Measures

Name	Time	Method
The number of cases that develop clinical rebleeding	Within 30 days of therapy	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.

Secondary Outcome Measures

Name	Time	Method
Hospital stay	up to one year	Hospital stay for the episode of bleeding
Number of units of blood transfusion required in each patient	within 30 days of therapy	Number of units of blood transfusion required in each patient within 30 days of therapy
Number of cases with failure of achieving primary haemostasis	Within 30 days of therapy	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.
Hospital costs	Up to one year	The total direct costs required for the hospital admission for the episode of bleeding measured in Hong Kong dollars
Number of cases that died	within 30 days of therapy	Death from all causes within 30 days of therapy
The number of cases requiring further interventions such as repeat endoscopy, surgery or transarterial embolization	Within 30 days of therapy	The number of cases requiring further interventions such as repeat endoscopy, surgery or transarterial embolization

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong