NCT05428553

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 183 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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).

Conditions

• Duodenal Tumor

Interventions

Type	Name	Description
PROCEDURE	Endoscopic resection: CSP/p-CSP	Patients in the experimental arm will be assigned to receive CSP/p-CSP.
PROCEDURE	Endoscopic resection: EMR/EPMR	Patients in the historical control arm have already finished EMR/EPMR

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-03-31
• Completion: 2023-11-30
• First posted: 2022-06-23
• Last updated: 2022-06-23

Locations

1 site across 1 country: China