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Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 14 words
  2. 2 versions Re-verified since Feb 5, 2025, no change to tracked fieldsv5-v6
  3. Eligibility criteria expanded, about 2 wordsv4
  4. Start date changed from estimate of Jul 1, 2023 to Apr 13, 2023v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to analyze if intraperitoneal drainage is necessary following distal pancreatectomy. This study aims to determine whether the omission of routine intraperitoneal drainage in the setting of reinforced staple technology is non-inferior to routine intraperitoneal drainage with respect to a composite post-operative complications of Grade B or C Postoperative pancreatic fistula (POPF), readmission, or organ space surgical site infection following a distal pancreatectomy.
Trial Details
NCT Number NCT05720338
Lead Sponsor Case Comprehensive Cancer Center
Conditions
(from sponsor)		 Cyst of Pancreas, Pancreatectomy, Pancreas Neoplasm
Related terms Pancreatic Cyst, Pancreatic Neoplasms
Enrollment 234 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov