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Endoscopic mucosal resection (EMR) has been widely used as a diagnostic and treatment techniques of gastrointestinal small lesions. Postoperative rebleeding is one of the common complication following EMR. Several endoscopic hemostasis methods are currently in use. EndoClot® absorbable polysaccharide hemostat (PAPH) as a new hemostasis material was previously used for surgical hemostasis, but the therapeutic effect and safety in endoscopic application remains unknown. This study has been designed to observe the effect of rebleeding prevention after EMR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Subjects in this group will received Endoclot treatment immediately after EMR. |
| |
| Control group | Subjects in this group will not received any hemostasis treatment after EMR. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EndoClot | Device | EndoClot hemostat is applied immediately after EMR to achieve hemostasis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rebleeding rate after EMR procedure | Rebleeding rate up to 1 week was obtained by clinical manifestations such as melana; decreased hemoglobin > 20g/L; hemodynamic instability or active bleeding from mucosal defect under endoscope. | up to 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Mucosal healing after EMR | Colonoscopy will be repeated 1 month after EMR procedure to observe if application of Endoclot will delay the musosal healing. | up to 1 month |
| gastrointestinal tract obstruction |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive cases of colorectal mucosal and submucosal lesions with intented EMR treatment
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| Name | Affiliation | Role |
|---|---|---|
| Zhiguo Liu, M.D. | Xijing Hospital of Digestive Diseases, Xi'an, Shaanxi, China 710032 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital of Digestive Diseases | Xi’an | Shanxi | 710032 | China |
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| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Gastrointestinal tract obstruction has been previously reported as a possible adverse effect of hemostats, therefore it was observed in the current study.
| up to 1 month |