Clinical Trial: Different Stapler Cartridge For Pancreatic Stump Texture To Prevent Pancreatic Fistula

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized Trail Of Different Stapler Cartridge For Pancreatic Stump Texture To Prevent Pancreatic Fistula After Laparoscopic Distal Pancreatectomy

Brief Summary: The purpose of this trial is to establish an objective criterion for assessing pancreatic stump texture, and unify stapler cartridge according to pancreatic stump texture and thickness.

Detailed Summary: Distal pancreatectomy (DP) is the standard treatment for symptomatic benign, premalignant, and malignant lesions in the pancreatic body and tail.Laparoscopic distal pancreatectomy (LDP) are reported to have lower blood loss, fewer postoperative complications and a shorter length of stay without a substantial increase in the operative time. Pancreatic fistula (PF) is the major source of postoperative morbidity and is associated with numerous further complications, suffering, longer hospital stay, higher costs and sometimes death. Frequencies range from 5% to 64%. Several procedures have been proposed to reduce the rate of PF. stapler closure is considered to be safe and approved particularly in LDP. Numerous predictive factors for PF have been reported in previous studies. Among these risk factors, the most important might be the texture and thickness of the remnant pancreas. However, the judgment of pancreatic texture has been based on the surgeon's observation and there still exists no objective method of assessing pancreatic texture. Furthermore there is no strict guideline on which type of cartridge to use according to pancreatic stump texture and thickness. Therefore, this single blind randomized controlled trial is designed to establish an objective criterion for assessing pancreatic stump texture, and unify stapler cartridge according to pancreatic stump texture and thickness. Patients were stratified intraoperatively by gland texture—hard (fibrotic) or soft (normal) and subsequently randomized according to different stapler cartridge. Pancreatic fibrosis is accessed by histopathology and pancreatic stellate cell.
Sponsor: Yi-Ping Mou

Current Primary Outcome:

  • Incidence of pancreatic fistula grade A/ B/C defined by ISGPF classification [ Time Frame: Thirty days after operation ]
    Pancreatic amylase concentration in any post operative drains. Fistula is diagnosed if pancreatic amylase > 3 times the upper normal limit of pancreatic amylase in plasma on post operative day 3 or later
  • Pancreatic fibrosis accessed by histopathology and pancreatic stellate cell [ Time Frame: intraoperative ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Morbidity [ Time Frame: Thirty days after operation ]
  • Mortality [ Time Frame: Thirty days after operation ]
  • Time to oral intake [ Time Frame: Duration of hospital stay ]
  • Postoperative hospital stay [ Time Frame: Duration of hospital stay ]
  • Readmission rate [ Time Frame: Thirty days after operation ]


Original Secondary Outcome: Same as current

Information By: Zhejiang Provincial People’s Hospital

Dates:
Date Received: May 31, 2016
Date Started: May 2016
Date Completion:
Last Updated: June 2, 2016
Last Verified: May 2016