High-risk Patients for Post-ESD Bleeding Clinical Trial
Official title:
Efficacy of Hemostatic Powder in Preventing Bleeding After Gastric Endoscopic Submucosal Dissection in High-risk Patients: A Prospective Randomized Control Study
| NCT number | NCT03169569 |
| Other study ID # | 4-2016-1147 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 1, 2017 |
| Est. completion date | May 9, 2019 |
| Verified date | March 2020 |
| Source | Yonsei University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 143 |
| Est. completion date | May 9, 2019 |
| Est. primary completion date | September 25, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 85 Years |
| Eligibility |
Inclusion Criteria: - 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) - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Department of Internal Medicine, | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | until 4 weeks after ESD | |
| Secondary | Bleeding rates according to the timing | early bleeding: 0~48 hours after ESD late bleeding: 2 days ~ 4 weeks after ESD | within 48 hours from 2 days to 4 weeks after ESD |