NCT04963868|UnknownDMC
Timing of Transmural Stent Removal in Necrotizing Pancreatitis
TTSRNP
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TTSRNP
Sponsor study identifier
interventional
156
1 country
1
Study Start
January 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 1, 2024
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Study Completion
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Although metal stents have been widely used in the endoscopic step-up approach for necrotizing pancreatitis, the exact timing of transmural stent removal has not been well studied. In this prospective, open-label, randomized controlled study, we recruited and enrolled consecutive patients with necrotizing pancreatitis undergoing endoscopic transmural necrosectomy. Eligible participants were randomly assigned to case group (a novel strategy in which the stents were removed during the last necrosectomy when the necrosectomy endpoint was achieved) and control group (the conventional strategy in which the stents were removed after the last necrosectomy when clinical symptoms were relieved and fluid was nearly completely resolved confirmed by imaging). The primary endpoint was the incidence of composite complications within three months of enrollment.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2025
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 21, 2021
Actual (reported)July 15, 2021
Actual (reported)January 1, 2022
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June 1, 2024
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December 1, 2025
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The incidence of composite complications
The composite complications included new-onset organ failure or systemic complications、new-onset infectious pancreatic necrosis、abdominal or gastrointestinal bleeding, intestinal fistula, stent occlusion and stent migration.
3 months
The incidence of technical success
3 months
The incidence of clinical success
3 months
The number of endoscopic transmural necrosectomy sessions
3 months
The number of additional endoscopic transmural necrosectomy sessions after stent removal
3 months
Length of stent placement
3 months
The stents were removed during the last necrosectomy when the endpoint of necrosectomy was achieved
The stent was removed after the last necrosectomy when clinical symptoms were relieved and fluid was nearly completely resolved confirmed by CT image
The stent was removed during the last necrosectomy when the endpoint of necrosectomy was achieved；
The stent was removed after the last necrosectomy when clinical symptoms were relieved and fluid was nearly completely resolved confirmed by CT image.
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Yin Zhu, PhD
The First Affiliated Hospital of Nanchang University
First Submitted
June 21, 2021
First Posted
July 15, 2021
Study Start
January 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 1, 2024
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Study Completion
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 15, 2021
Record last verified: 2021-07
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