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There is currently no reliable evidence on the safety of CSP (cold snare polypectomy) / p-CSP (piecemeal CSP) for SNADT greater than 6mm.In this prospective historical controlled study, we intend to test the role of CSP / p-CSP in the treatment of pedicle less snadt greater than 6mm compared with EMR (endoscopic mucosal resection) / EPMR (endoscopic piecemeal mucosal resection).
Due to the possibility of malignant transformation of duodenal adenomatous lesions, endoscopic resection is recommended as far as possible. The European Society of endoscopy guidelines recommend cold snare polypectomy for superficial non ampullary duodenal tumors (SNADT) less than 6mm in diameter, while EMR (endoscopic mucosal resection) is recommended as a first-line endoscopic resection for other larger lesions. ESD (endoscopic submucosal dissection) is not considered as the standard treatment of duodenum due to its difficult operation and high complication rate.
In recent years, CSP (cold snare polypectomy) has been widely used in the colon. CSP is a safe alternative method of directly removing polyps with snare without electrifying. Reducing electrocoagulation can reduce the damage of peripheral blood vessels and intestinal wall, leading to decreased risk of delayed bleeding and perforation. CSP has gradually replaced EMR in the resection of colorectal lesions of appropriate size.
So far, there is no reliable evidence on the safety of CSP / p-CSP (piecemeal CSP) for SNADT greater than 6mm.In this prospective historical controlled study, we intend to test the role of CSP / p-CSP in the treatment of pedicle less snadt greater than 6mm compared with EMR / EPMR (endoscopic piecemeal mucosal resection).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSP/p-CSP | Experimental | Prospective allocation |
|
| EMR/EPMR | Active Comparator | Historical control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic resection: CSP/p-CSP | Procedure | Patients in the experimental arm will be assigned to receive CSP/p-CSP. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | iIntraoperative and postoperative adverse events; through medical records and telephone follow up | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative adverse events | postoperative adverse events; through medical records and telephone follow up | 2 weeks |
| Clinically significant delayed bleeding | Leading to emergency room visit, readmission, or intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Cost | total cost of hospitalization | 2 weeks |
| Number of treatment after technical failure | through medical records and telephone follow up | 6 months |
Inclusion Criteria:
Experimental arm: CSP/p-CSP
Control arm: EMR/EPMR
Exclusion Criteria:
Experimental arm: CSP/p-CSP
Control arm: EMR/EPMR
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin-Yang Liu, MD,MPH | Contact | 13661802849 | liu.xinyang@zs-hospital.sh.cn | |
| Quan-Lin Li, MD,PhD | Contact | 13564671882 | li.quanlin@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ping-Hong Zhou, MD,PhD | Shanghai Zhongshan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Zhongshan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
Original data could be shared at request by email after publication
The data will be available after publication of the study
The shared data could be available by contacting Dr. Xin-Yang Liu at shmulxy@163.com.
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| ID | Term |
|---|---|
| D004379 | Duodenal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Endoscopic resection: EMR/EPMR | Procedure | Patients in the historical control arm have already finished EMR/EPMR |
|
| 2 weeks |
| Delayed perforation | Image confirmed | 2 weeks |
| Clinically significant intra-procedural bleeding Intraoperative adverse events Delayed perforation | Not responsive to water flushing and clips are needed | intra-procedural |
| Intraoperative deep mural injury | stage III/IV/V | intra-procedural |
| En bloc resection | specimen resected in one piece | intra-procedural |
| Procedure duration | the entire duration of the procedure, not including ascending of the scope and looking for the lesions | intra-procedural |
| Recurrence after 6 months | confirmed by colonoscopy | 6 months |
| Number of clips | number of clips used to close the wound | intra-procedural |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |