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A prospective, single-center, open-label, randomized controlled study to compare the effectiveness and safety of endoscopic mucosal resection (EMR) and cold snare polypectomy (CSP) in treating colorectal sessile serrated lesions (SSLs) less than 10mm in size.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMR in treating SSLs less than 10mm in size | Experimental | The EMR procedure included the following: (1) needle injection of normal saline into the submucosa; (2) entrapment of the mucosal protrusion with a snare; and (3) resection using electrocautery |
|
| CSP in treating SSLs less than 10mm in size | Active Comparator | The CSP procedure included the following: (1) entrapment and resection of the polyp with a snare without electrocautery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopic mucosal resection | Procedure | The SSLs less than 10mm in size in this group will be treated by EMR |
|
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection | Rate of R0 resection in treating SSLs less than 10mm in size | 2 weeks after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| en bloc resection | Rate of en bloc resection rate in treating SSLs less than 10mm in size | immediately after the procedure |
| Vertical margins | Rate of negative vertical margins in resected specimen |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danian Ji, M.D. | Contact | +86-18019094606 | arctg4@163.com | |
| Zhiyu Dong, M.D. | Contact | +86-18817870866 | 18817870866@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Danian Ji, M.D. | Huadong Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huadong hospital affiliated to Fudan university | Shanghai | 200040 | China |
All collected IPD
1 year after completion of this study
All researchers can require the original data from principal investigator of this study (Email address: arctg4@163.com)
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| ID | Term |
|---|---|
| D000069916 | Endoscopic Mucosal Resection |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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| Cold snare polypectomy | Procedure | The SSLs less than 10mm in size in this group will be treated by CSP |
|
| 2 weeks after the procedure |
| Lateral margin | Rate of negative lateral margin in resected specimen | 2 weeks after the procedure |
| Presence of muscularis mucosae | Rate of presence of muscularis mucosae in resected specimen | 2 weeks after the procedure |
| Presence of submucosa | Rate of presence of submucosa in resected specimen | 2 weeks after the procedure |
| Clinically Significant Immediate Post-polypectomy Bleeding(CSIPB) | CSIPB was defined as any bleeding not responding to water jet irrigation or STSC and therefore requiring either coagu lation forceps or mechanical clips to achieve hemostasis | immediately after the procedure |
| Clinically Significant Delayed Post-polypectomy Bleeding(CSDPB) | CSPEB was defined as any bleeding after completion of the procedure requiring emergency room presentation, hospital isation or re-intervention (endoscopy, angiography, surgery). | 2 weeks after the procedure |
| Delayed perforation | Rate of delayed perforation in treating SSLs less than 10mm in size | 2 weeks after the procedure |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |