CSP; EMR
Endoscopic Cold Snare Polypectomy Versus Endoscopic Mucosal Resection of Superficial Non-ampullary Duodenal Tumors (SNADTs) (>6mm, Sessile) - A Prospective Multicenter Historically Controlled Trial
Sponsor study identifier
interventional
183
1 country
1
Study Start
June 1, 2022
Actual (reported)Primary Completion
March 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 20, 2022
Actual (reported)June 1, 2022
Actual (reported)June 23, 2022
Actual (reported)March 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Adverse events
iIntraoperative and postoperative adverse events; through medical records and telephone follow up
2 weeks
Postoperative adverse events
2 weeks
Clinically significant delayed bleeding
2 weeks
Delayed perforation
2 weeks
Clinically significant intra-procedural bleeding Intraoperative adverse events Delayed perforation
intra-procedural
Intraoperative deep mural injury
intra-procedural
Cost
2 weeks
Number of treatment after technical failure
6 months
Number of clips
intra-procedural
Prospective allocation
Historical control
Patients in the experimental arm will be assigned to receive CSP/p-CSP.
Patients in the historical control arm have already finished EMR/EPMR
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032, China
Ping-Hong Zhou, MD,PhD
Shanghai Zhongshan Hospital
First Submitted
March 20, 2022
First Posted
June 23, 2022
Study Start
June 1, 2022
Actual (reported)Primary Completion
March 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Study Completion
November 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 23, 2022
Record last verified: 2022-03
Original data could be shared at request by email after publication
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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