High-risk Patients for Post-ESD BleedingNCT03169569
Efficacy of Hemostatic Powder in Preventing Bleeding After Gastric Endoscopic Submucosal Dissection in High-risk Patients: A Prospective Randomized Control Study
A study testing Endo-clot™ (EndoClot Plus, Unc., Santa Clara, CA, USA) group and Hemostatic forceps Only (Coagrasper®, Olympus, Japan) group in people with High-risk Patients for Post-ESD Bleeding, run by Yonsei University at 1 site in South Korea.
Trial summary
Endoscopic submucosal dissection (ESD) for superficial gastric neoplasm is minimally invasive and achieves curative resection with an acceptable rate of adverse events. Although the safety of ESD has been demonstrated, the procedure is associated with a substantial risk of adverse events, including bleeding… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- High-risk Patients for Post-ESD Bleeding
- What is being tested?
- Endo-clot™ (EndoClot Plus, Unc., Santa Clara, CA, USA) group and Hemostatic forceps Only (Coagrasper®, Olympus, Japan) group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2017to 9 May 2019
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 19 years old and younger than 85 years old
- Pathologically confirmed gastric adenoma and/or early gastric cancer
- Iatrogenic gastric ulcer after ESD (Endoscopic submucosal dissection) more than 40mm (at prediction)
- Patients who is taking antithrombotic drug such as aspirin and/or coumadin (and other anti-coagulation medication)
- ECOG performance status 0 or 1
- Adequate renal function (serum creatinine < 1.5 mg/dL or calculated creatinine clearance ≥ 60 ml/min)
Show all 9Show fewer
- Adequate liver function (total bilirubin < 1.5 X the upper limits of normal (ULN), AST and ALT <3 X UNL, and alkaline phosphatases < 3 X ULN or < 5 x ULN in case of liver involvement)
- Adequate BM function (WBC ≥ 3,500/µl, absolute neutrophil cell count ≥ 1,500 /µl, platelet count ≥ 100,000/µl)
- Subjects who given written informed consent after being given a full description of the study
Who cannot join
- Previously treated by radical gastrectomy
- Adverse effect on this medication
- Pregnant or on breast feeding
- Patients who are unwilling or unable to provide informed consent, such as those with psychiatric problem, drug abuse or alcoholism
Trial locations and contacts
1 site in 1 country.
About this study
Endoscopic submucosal dissection (ESD) for superficial gastric neoplasm is minimally invasive and achieves curative resection with an acceptable rate of adverse events. Although the safety of ESD has been demonstrated, the procedure is associated with a substantial risk of adverse events, including bleeding, perforation, and stricture.
Post-ESD bleeding is the most frequent adverse events and the incidence of post-ESD bleeding in previous studies ranges from 1.8% to 15.6%. Several studies identified that antithrombotic agents and large resection size were strong risk factors for post-ESD bleeding. Moreover, the incidence of bleeding in high-risk patients has been reported to be as high as 61.5%, depending on the definition of high-risk patients. The number of patients at high risk for post-ESD bleeding is increasing worldwide. In addition, as the indications for ESD have been expanding, more patients with large lesions undergo ESD. Therefore, it is important to prevent post-ESD bleeding in high-risk patients.
Read more
Although several previous studies have attempted to prevent post-ESD bleeding using surgical material, there is no definite prophylactic treatment to prevent re-bleeding after ESD. To date, coagulation of remnant vessels on the post-resection ulcer surface and administration of a proton pump inhibitor (PPI) after ESD are practical methods to prevent post-ESD bleeding.
Polysaccharide hemostatic powder (Endo-Clot™) is a new topical hemostatic method recently used for non-variceal upper gastrointestinal bleeding. This study aimed to identify the efficacy of hemostatic powder in preventing post-ESD bleeding in high-risk patients. This is a multicenter, prospective, randomized study.
Read the detailed description
A multicenter, prospective, randomized controlled study
- High-risk patients of post-ESD bleeding will be prospectively enrolled in the study. High-risk of post-ESD bleeding is defined as patients with taking antithrombotic agents or with large resection (specimen size ≥ 40mm).
- All ESDs were performed according to the standard procedure sequence in the hemostatic powder group and control group. The Only difference between two groups was hemostatic powder (Endo-clot™) application after standard hemostasis using hemostatic forceps in the hemostatic powder group. For patients in the study group, after hemostasis on the post-resection ulcer using conventional method and removal of specimen, Endo-clot™ (EndoClot Plus, Unc., Santa Clara, CA, USA) was applied immediately onto the post-resection surface.
- Bleeding rate of study group within 4 weeks after ESD will be compared with the control group. "
- Conditions
- High-risk Patients for Post-ESD Bleeding
- Being tested
- Endo-clot™ (EndoClot Plus, Unc., Santa Clara, CA, USA) group, Hemostatic forceps Only (Coagrasper®, Olympus, Japan) group
- Keywords
- hemostatic powder, post-ESD bleeding, antithrombotic therapy, high risk of bleeding, endoscopic submucosal dissection, adverse event
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endo-clot™ (EndoClot Plus, Unc., Santa Clara, CA, USA) groupProcedure or surgery
Also called Endo-clot™ group
For patients in the study group, after hemostasis on the post-resection ulcer using conventional method and removal of specimen, Endo-clot™ (EndoClot Plus, Unc., Santa Clara, CA, USA) was applied immediately onto the post-resection surface.
Hemostatic forceps Only (Coagrasper®, Olympus, Japan) groupProcedure or surgery
All ESDs were performed according to the standard procedure sequence in the hemostatic group and control group except hemostatic powder application.
| Study group | Role | What they receive |
|---|---|---|
| Hemostatic powder group (Endo-clot™ group) | Experimental | Patients who will undergo ESD with Endo-clot™ (EndoClot Plus, Unc., Santa Clara, CA, USA) after hemostasis on the post-resection ulcer using conventional method and removal of specimen. Receives: Procedure: Endo-clot™ (EndoClot Plus, Unc., Santa Clara, CA, USA) group |
| Hemostatic forceps Only (Coagrasper®, Olympus, Japan) group | Active comparator | For patients in the control group, hemostasis with conventional method (electrical coagulation and/or clip, Coagrasper®, Olympus, Japan) will be done. Receives: Procedure: Hemostatic forceps Only (Coagrasper®, Olympus, Japan) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding rate until 4 weeks after ESD
Post-ESD bleeding was defined by clinical symptoms or laboratory findings. Clinical symptoms such as melena, hematemesis were defined as bleeding signs. A decrease of hemoglobin of 2.0 g/dL was defined as laboratory bleeding sign.
Measured: until 4 weeks after ESD
Secondary outcomes (1)
Bleeding rates according to the timing
early bleeding: 0~48 hours after ESD late bleeding: 2 days ~ 4 weeks after ESD
Measured: within 48 hours from 2 days to 4 weeks after ESD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start1 May 2017
- Primary completion25 Sep 2018
- Study completion9 May 2019
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 High-risk Patients for Post-ESD BleedingStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All procedures were performed according to the standard procedure sequence in the hemostatic powder group and control group. The Only difference between two groups was hemostatic powder (Endo-clot™) application after standard hemostasis using hemostatic forceps in the hemostatic powder group. For patients in the study group, after hemostasis on the post-resection ulcer using conventional method and removal of specimen, Endo-clot™ (EndoClot Plus, Unc., Santa Clara, CA, USA) was applied immediately onto the post-resection surface.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03169569
- Sponsor's protocol ID
- 4-2016-1147
- Status last verified
- Mar 2020
- First submitted
- 16 May 2017
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Jung DH, Moon HS, Park CH, Park JC. Polysaccharide hemostatic powder to prevent bleeding after endoscopic submucosal dissection in high risk patients: a randomized controlled trial. Endoscopy. 2021 Oct;53(10):994-1002. doi: 10.1055/a-1312-9420. Epub 2021 Feb 18.
PubMed 33200808
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hemostatic Powder in Preventing Bleeding After Gastric Endoscopic Submucosal Dissection in High-risk Patients: A Prospective Randomized Control Study
- ClinicalTrials.gov ID
- NCT03169569
- Acronym / sponsor ID
- 4-2016-1147
- Conditions
- High-risk Patients for Post-ESD Bleeding
- Keywords
- hemostatic powder, post-ESD bleeding, antithrombotic therapy, high risk of bleeding, endoscopic submucosal dissection, adverse event
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 25 Sep 2018 (actual)
- Study completion
- 9 May 2019 (actual)
- First posted
- 30 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.
Endoscopic submucosal dissection (ESD) for superficial gastric neoplasm is minimally invasive and achieves curative resection with an acceptable rate of adverse events. Although the safety of ESD has been demonstrated, the procedure is associated with a substantial risk of adverse events, including bleeding, perforation, and stricture.
Post-ESD bleeding is the most frequent adverse events and the incidence of post-ESD bleeding in previous studies ranges from 1.8% to 15.6%. Several studies identified that antithrombotic agents and large resection size were strong risk factors for post-ESD bleeding. Moreover, the incidence of bleeding in high-risk patients has been reported to be as high as 61.5%, depending on the definition of high-risk patients. The number of patients at high risk for post-ESD bleeding is increasing worldwide. In addition, as the indications for ESD have been expanding, more patients with large lesions undergo ESD. Therefore, it is important to prevent post-ESD bleeding in high-risk patients.
Although several previous studies have attempted to prevent post-ESD bleeding using surgical material, there is no definite prophylactic treatment to prevent re-bleeding after ESD. To date, coagulation of remnant vessels on the post-resection ulcer surface and administration of a proton pump inhibitor (PPI) after ESD are practical methods to prevent post-ESD bleeding.
Polysaccharide hemostatic powder (Endo-Clot™) is a new topical hemostatic method recently used for non-variceal upper gastrointestinal bleeding. This study aimed to identify the efficacy of hemostatic powder in preventing post-ESD bleeding in high-risk patients. This is a multicenter, prospective, randomized study.
Detailed description
A multicenter, prospective, randomized controlled study
- High-risk patients of post-ESD bleeding will be prospectively enrolled in the study. High-risk of post-ESD bleeding is defined as patients with taking antithrombotic agents or with large resection (specimen size ≥ 40mm).
- All ESDs were performed according to the standard procedure sequence in the hemostatic powder group and control group. The Only difference between two groups was hemostatic powder (Endo-clot™) application after standard hemostasis using hemostatic forceps in the hemostatic powder group. For patients in the study group, after hemostasis on the post-resection ulcer using conventional method and removal of specimen, Endo-clot™ (EndoClot Plus, Unc., Santa Clara, CA, USA) was applied immediately onto the post-resection surface.
- Bleeding rate of study group within 4 weeks after ESD will be compared with the control group. "
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- All procedures were performed according to the standard procedure sequence in the hemostatic powder group and control group. The Only difference between two groups was hemostatic powder (Endo-clot™) application after standard hemostasis using hemostatic forceps in the hemostatic powder group. For patients in the study group, after hemostasis on the post-resection ulcer using conventional method and removal of specimen, Endo-clot™ (EndoClot Plus, Unc., Santa Clara, CA, USA) was applied immediately onto the post-resection surface.
| Arm | Type | Receives |
|---|---|---|
| Hemostatic powder group (Endo-clot™ group) | Experimental | Procedure: Endo-clot™ (EndoClot Plus, Unc., Santa Clara, CA, USA) groupPatients who will undergo ESD with Endo-clot™ (EndoClot Plus, Unc., Santa Clara, CA, USA) after hemostasis on the post-resection ulcer using conventional method and removal of specimen. |
| Hemostatic forceps Only (Coagrasper®, Olympus, Japan) group | Active comparator | Procedure: Hemostatic forceps Only (Coagrasper®, Olympus, Japan) groupFor patients in the control group, hemostasis with conventional method (electrical coagulation and/or clip, Coagrasper®, Olympus, Japan) will be done. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Older than 19 years old and younger than 85 years old
- Pathologically confirmed gastric adenoma and/or early gastric cancer
- Iatrogenic gastric ulcer after ESD (Endoscopic submucosal dissection) more than 40mm (at prediction)
- Patients who is taking antithrombotic drug such as aspirin and/or coumadin (and other anti-coagulation medication)
- ECOG performance status 0 or 1
Key exclusion criteria (4 listed)
- Previously treated by radical gastrectomy
- Adverse effect on this medication
- Pregnant or on breast feeding
- Patients who are unwilling or unable to provide informed consent, such as those with psychiatric problem, drug abuse or alcoholism
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 |
|---|---|---|
| Endo-clot™ (EndoClot Plus, Unc., Santa Clara, CA, USA) groupAlso: Endo-clot™ groupFor patients in the study group, after hemostasis on the post-resection ulcer using conventional method and removal of specimen, Endo-clot™ (EndoClot Plus, Unc., Santa Clara, CA, USA) was applied immediately onto the post-resection surface. | Procedure or surgery | Hemostatic powder group (Endo-clot™ group) |
| Hemostatic forceps Only (Coagrasper®, Olympus, Japan) groupAll ESDs were performed according to the standard procedure sequence in the hemostatic group and control group except hemostatic powder application. | Procedure or surgery | Hemostatic forceps Only (Coagrasper®, Olympus, Japan) group |
Primary outcome
Bleeding rate until 4 weeks after ESD
Time frame: until 4 weeks after ESD
Post-ESD bleeding was defined by clinical symptoms or laboratory findings. Clinical symptoms such as melena, hematemesis were defined as bleeding signs. A decrease of hemoglobin of 2.0 g/dL was defined as laboratory bleeding sign.
1 secondary outcome
Bleeding rates according to the timing
Time frame: within 48 hours from 2 days to 4 weeks after ESD
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 17 Mar 2020.
- Derived from this study: PubMed 33200808Jung DH, Moon HS, Park CH, Park JC. Polysaccharide hemostatic powder to prevent bleeding after endoscopic submucosal dissection in high risk patients: a randomized controlled trial. Endoscopy. 2021 Oct;53(10):994-1002. doi: 10.1055/a-1312-9420. Epub 2021 Feb 18.
- Individual participant dataSharing planned: Yes
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endo-clot™ (EndoClot Plus, Unc., Santa Clara, CA, USA) group and Hemostatic forceps Only (Coagrasper®, Olympus, Japan) group in people with High-risk Patients for Post-ESD Bleeding, run by Yonsei University at 1 site in South Korea.
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 9 inclusion and 4 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 17 Mar 2020. 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 South Korea. 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?
Bleeding rate until 4 weeks after ESD (time frame: until 4 weeks after ESD). 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 NCT03169569, 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 17 Mar 2020.