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

NCT03160911 | Completed DMC FDA Device

• 1 other identifier: 2016.711-T
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcer Bleeding; Upper Gastrointestinal Tract Bleeding

Keywords

Over-the-scope clip; endoscopic haemostasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Number of cases that died

  within 30 days of therapy

• Number of units of blood transfusion required in each patient

  within 30 days of therapy

• Hospital stay

  up to one year

• Number of cases with failure of achieving primary haemostasis

  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

Study Arms (2)

Over-the-scope clip

EXPERIMENTAL

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)

Conventional endoscopic haemostasis

ACTIVE COMPARATOR

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

Interventions

Over-the-scope clip (OTSC) DEVICE

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

Over-the-scope clip

Conventional Endoscopic Haemostasis DEVICE

This includes the use of heater probe, endoscopic clipping and injection of adrenaline for endoscopic haemostasis

Conventional endoscopic haemostasis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Ulcer size ≥ 1.5 cm as determined by an opened biopsy forceps;

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, 00000, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 36307177 DERIVED

Study Officials

• Shannon M Chan, MBCHB, FRCS

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participant, the investigator and the outcome assessor would be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Specialist

Model Details: There are two separate interventional arms. In case of treatment failure, the two groups are allowed to crossover to the other group.

Study Record Dates

• First Submitted: May 14, 2017
• First Posted: May 19, 2017
• Study Start: March 16, 2018
• Primary Completion: August 31, 2021
• Study Completion: February 28, 2022
• Last Updated: July 8, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)