Superficial Non-ampullary Duodenal Tumors
Conditions
Interventions
Experimental arm:Endoscopic Cold Snare Polypectomy
Control arm:EMR/EPMR
Sponsors
Zhongshan Hospital Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Experimental arm: CSP/p-CSP: 1.Patients of age 18-75 years; 2.Lesion located in the duodenum; 3.Superficial non-ampullary duodenal tumors (SNADTs) (>6mm, Sessile); 4.Written informed consent; 5.Benign adenomatous surface features (Kudo III / IV, JNET 2a); 6.If present, sessile component may be no greater than 10mm in size. Control arm: EMR/EPMR 1.Patients of age 18-75 years; 2.Lesion located in the duodenum; 3.Superficial non-ampullary duodenal tumors (SNADTs) (>6mm, Sessile); 4.Benign adenomatous surface features (Kudo III / IV, JNET 2a); 5.Received EMR/EPMR already; 6.Provided written informed consent for use of clinical information.
Exclusion criteria
Exclusion criteria: Experimental arm: CSP/p-CSP: 1.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=1.5) at the time of EMR/EPMR. 2.History of surgery in the stomach or duodenum (endoscopic surgery not included), or receiving chemotherapy/radiotherapy at the time of EMR/EPMR. 3.Pregnant or breast feeding at the time of EMR/EPMR. 4.Lesions involving the ampullary area. 5.Endoscopic features suggestive of submucosal invasion (Kudo Vi/n, JNET 2b / 3). 6.Scar of previous endoscopic procedures within 10mm around the lesion. Control arm: EMR/EPMR 1.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=1.5). 2.History of surgery in the stomach or duodenum (endoscopic surgery not included), or receiving chemotherapy/radiotherapy. 3.Pregnant or breast feeding. 4.Lesions involving the ampullary area. 5.Endoscopic features suggestive of submucosal invasion (Kudo Vi/n, JNET 2b / 3). 6.Scar of previous endoscopic procedures within 10mm around the lesion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical failure;Postoperative adverse events;Clinically significant delayed bleeding;Delayed perforation;Intraoperative adverse events;Clinically significant intra-procedural bleeding;Intraoperative deep mural injury;En bloc resection;Procedure duration;Recurrence after 6 months; | — |
Countries
China
Contacts
Public ContactPinghong Zhou
Zhongshan Hospital Fudan University
Outcome results
None listed