Clinical Trial: The Use of Over-the-scope-clip for Prevention of Rebelling in High Risk Peptic Ulcers

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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.

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 Summary:

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.


Sponsor: Chinese University of Hong Kong

Current Primary Outcome: The number of cases that develop clinical rebleeding [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Chinese University of Hong Kong

Dates:
Date Received: May 14, 2017
Date Started: May 22, 2017
Date Completion: December 1, 2019
Last Updated: May 17, 2017
Last Verified: May 2017