Ulcer BleedingNCT03160911
The Use of Over-the-scope-clip for Prevention of Rebleeding in High Risk Peptic Ulcers
A study testing Over-the-scope clip (OTSC) and Conventional Endoscopic Haemostasis in people with Ulcer Bleeding and Upper Gastrointestinal Tract Bleeding, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcer Bleeding, Upper Gastrointestinal Tract Bleeding
- What is being tested?
- Over-the-scope clip (OTSC) and Conventional Endoscopic Haemostasis
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteHong Kong
- Study dates
- 16 Mar 2018to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Being tested
- Over-the-scope clip (OTSC), Conventional Endoscopic Haemostasis
- Keywords
- Over-the-scope clip, endoscopic haemostasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Conventional Endoscopic HaemostasisDevice
This includes the use of heater probe, endoscopic clipping and injection of adrenaline for endoscopic haemostasis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Device: Conventional Endoscopic Haemostasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 30 days of therapy
Secondary outcomes (6)
Number of cases that died
Death from all causes within 30 days of therapy
Measured: 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
Measured: within 30 days of therapy
Hospital stay
Hospital stay for the episode of bleeding
Measured: 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.
Measured: 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
Measured: 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
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start16 Mar 2018
- Primary completion31 Aug 2021
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcer BleedingStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two separate interventional arms. In case of treatment failure, the two groups are allowed to crossover to the other group.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHAN SHANNON MELISSA, Chinese University of Hong Kong
- Investigators
- Shannon M Chan, MBCHB, FRCS, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160911
- Sponsor's protocol ID
- 2016.711-T
- Status last verified
- Jul 2022
- First submitted
- 14 May 2017
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The IPD will only be used for the purposes of this study and not be disclosed to researchers of outside of this study.
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. 2023 Apr;72(4):638-643. doi: 10.1136/gutjnl-2022-327007. Epub 2022 Oct 28.
PubMed 36307177
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03160911
- Acronym / sponsor ID
- 2016.711-T
- Keywords
- Over-the-scope clip, endoscopic haemostasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 19 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- There are two separate interventional arms. In case of treatment failure, the two groups are allowed to crossover to the other group.
| Arm | Type | Receives |
|---|---|---|
| Over-the-scope clip | Experimental | Device: 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. |
| Conventional endoscopic haemostasis | Active comparator | Device: Conventional Endoscopic HaemostasisThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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;
Key exclusion criteria (6 listed)
- Patients aged below 18
- Peptic ulcer with concomitant perforation
- Tumor bleeding
- Variceal bleeding
- Patients who are pregnant or lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Over-the-scope clip |
| Conventional Endoscopic HaemostasisThis includes the use of heater probe, endoscopic clipping and injection of adrenaline for endoscopic haemostasis | Device | Conventional endoscopic haemostasis |
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.
6 secondary outcomes
Number of cases that died
Time frame: within 30 days of therapy
Number of units of blood transfusion required in each patient
Time frame: within 30 days of therapy
Hospital stay
Time frame: up to one year
Number of cases with failure of achieving primary haemostasis
Time frame: Within 30 days of therapy
The number of cases requiring further interventions such as repeat endoscopy, surgery or transarterial embolization
Time frame: Within 30 days of therapy
Hospital costs
Time frame: Up to one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- Derived from this study: PubMed 36307177Chan 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.
- Individual participant dataSharing planned: No. The IPD will only be used for the purposes of this study and not be disclosed to researchers of outside of this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shannon M Chan, MBCHB, FRCS principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Over-the-scope clip (OTSC) and Conventional Endoscopic Haemostasis in people with Ulcer Bleeding and Upper Gastrointestinal Tract Bleeding, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of cases that develop clinical rebleeding (time frame: Within 30 days of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03160911, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2022.