Prophylactic Pancreatic Stent for the Prevention of Post Operative Pancreatic Fistula

Overview

Postoperative pancreatic fistula (POPF) remains one of the most harmful complications after pancreatic resection. Some studies have indicated that endoscopic pancreatic stenting was effective in the treatment of POPF. However, the results of prospective RCTs for the prophylactic effect of pancreatic stent insertion against POPF were controversial. This single center prospective randomized trial was designed to compare the outcome after segmental pancreatectomy with prophylactic drainage stent versus no stent.

Full Title of Study: “Prophylactic Pancreatic Stent for the Prevention of Post Operative Pancreatic Fistula Before Segmental Pancreatectomy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2021

Interventions

  • Device: Prophylactic pancreatic stent
    • Prophylactic pancreatic stent before segmental pancreatic surgery

Arms, Groups and Cohorts

  • Experimental: Stent
    • Prophylactic pancreatic stent before segmental pancreatic surgery
  • No Intervention: No stent
    • No prophylactic stent before surgery

Clinical Trial Outcome Measures

Primary Measures

  • Postoperative pancreatic fistula
    • Time Frame: from postoperative day 3 to 30
    • Grade B and C

Secondary Measures

  • Severity of pancreatic fistula
    • Time Frame: from postoperative day 3 to 30
    • Grade B POPF requires changes in clinical management, such as persistent drainage, partial or total parenteral nutrition, antibiotics, enteral nutrition, somatostatin analogs, and/or minimal invasive drainage. Grade C POPF requires major changes in management, such as admission to an intensive care unit, reoperation, and/or an extended hospital stay.
  • Length of stay
    • Time Frame: from postoperative day 1 to discharge
    • Length of hospital stay

Participating in This Clinical Trial

Inclusion Criteria

  • All patients scheduled for elective segmental pancreatectomy Exclusion Criteria:

  • Subjects for whom ERCP procedures are contraindicated – If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding – Age less than 18 year – Emergency surgery – Previous pancreatic surgery

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Peking Union Medical College Hospital
  • Provider of Information About this Clinical Study
    • Sponsor

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