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

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.

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.

Study Overview

• Status: Completed
• Conditions: Ulcer Bleeding; Upper Gastrointestinal Tract Bleeding
• Intervention / Treatment: Device: Over-the-scope clip (OTSC); Device: Conventional Endoscopic Haemostasis

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 00000
    • Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Over-the-scope clip; 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.	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
Active Comparator: 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	Device: Conventional Endoscopic Haemostasis; This includes the use of heater probe, endoscopic clipping and injection of adrenaline for endoscopic haemostasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of cases that died	Death from all causes within 30 days of therapy	within 30 days of therapy
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
Hospital stay	Hospital stay for the episode of bleeding	up to one year
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
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
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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Shannon M Chan, MBCHB, FRCS, Chinese University of Hong Kong

Publications and helpful links

General Publications

• 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. 2022 Oct 28:gutjnl-2022-327007. doi: 10.1136/gutjnl-2022-327007. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2018
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: May 14, 2017
• First Submitted That Met QC Criteria: May 17, 2017
• First Posted (Actual): May 19, 2017

Study Record Updates

• Last Update Posted (Actual): July 8, 2022
• Last Update Submitted That Met QC Criteria: July 7, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Over-the-scope clip; endoscopic haemostasis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Duodenal Diseases; Ulcer; Hemorrhage; Peptic Ulcer; Coagulants; Hemostatics
• Other Study ID Numbers: 2016.711-T

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The IPD will only be used for the purposes of this study and not be disclosed to researchers of outside of this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes