CSP vs EMR for >6mm Superficial Non-ampullary Duodenal Tumors

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

Official Title
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Endoscopic Cold Snare Polypectomy Versus Endoscopic Mucosal Resection of Superficial Non-ampullary Duodenal Tumors (SNADTs) (>6mm, Sessile) - A Prospective Multicenter Historically Controlled Trial

Conditions
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Duodenal Tumor

Intervention / Treatment
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* Procedure: Endoscopic resection: CSP/p-CSP
* Procedure: Endoscopic resection: EMR/EPMR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Experimental arm: CSP/p-CSP Patients of age 18-75 years. Lesion located in the duodenum. Superficial non-ampullary duodenal tumors (SNADTs) (>6mm, Sessile). Written informed consent. Benign adenomatous surface features (Kudo III / IV, JNET(Japan NBI (narrow-band imaging) Expert Team) 2a). Control arm: EMR/EPMR Patients of age 18-75 years. Lesion located in the duodenum. Superficial non-ampullary duodenal tumors (SNADTs) (>6mm, Sessile). Benign adenomatous surface features (Kudo III / IV, JNET 2a). Received EMR/EPMR already. Provided written informed consent for use of clinical information. Exclusion Criteria: Experimental arm: CSP/p-CSP Absence of proper suspension of the anticoagulant/antiplatelet therapy prior to procedure according to usual pre-procedure recommendations according to the guidelines, or presence of coagulation disorder （PLT (platelet)<50×10^9 / L or INR (international normalized ratio)≥1.5) at the time of EMR/EPMR. History of surgery in the stomach or duodenum (endoscopic surgery not included), or receiving chemotherapy/radiotherapy at the time of EMR/EPMR. Pregnant or breast feeding at the time of EMR/EPMR. Lesions involving the ampullary area. Endoscopic features suggestive of submucosal invasion (Kudo Vi/n, JNET 2b / 3). Scar of previous endoscopic procedures within 10mm around the lesion. Control arm: EMR/EPMR Absence of proper suspension of the anticoagulant/antiplatelet therapy prior to procedure according to usual pre-procedure recommendations according to the guidelines, or presence of coagulation disorder （PLT<50×10^9 / L or INR≥1.5)；. History of surgery in the stomach or duodenum (endoscopic surgery not included), or receiving chemotherapy/radiotherapy. Pregnant or breast feeding. Lesions involving the ampullary area. Endoscopic features suggestive of submucosal invasion (Kudo Vi/n, JNET 2b / 3). Scar of previous endoscopic procedures within 10mm around the lesion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CSP/p-CSP<br>Prospective allocation | Procedure: Endoscopic resection: CSP/p-CSP<br>* Patients in the experimental arm will be assigned to receive CSP/p-CSP.<br>|
| Active Comparator: EMR/EPMR<br>Historical control | Procedure: Endoscopic resection: EMR/EPMR<br>* Patients in the historical control arm have already finished EMR/EPMR<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | iIntraoperative and postoperative adverse events; through medical records and telephone follow up | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |