Clinical Trial: Use of Polyethylene Glycolic Acid or Tachocomb to Prevent Pancreatic Fistula Following Distal Pancreatectomy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Use of Polyethylene Glycolic Acid or Tachocomb to Prevent Pancreatic Fistula Following Distal Pancreatectomy: Prospective Multicenter Randomized Study

Brief Summary: To date, there has been many methods suggested to reduce pancreatic fistula. But there are no evidence of superiority to the other methods. This study is a multicenter prospective randomized phase III study of use of Tachocomb or Polyethylene Glycolic Acid (PGA) to prevent of pancreatic fistula after distal pancreatectomy.

Detailed Summary:

Distal pancreatectomy has been called to by various names such as, left-sided pancreatectomy, distal partial pancreatectomy. It is difficult to define which part of the pancreas as distal in exactly, but typically the superior mesenteric vein (SMV) and splenic vein, come to meet portal vein to form the area that covers the pancreas, neck actually based on a relatively thin pancreatic resection area, if left to its distal pancreatic resection is generally defined as that.

Indication of distal pancreatectomy in Western countries have been trauma (16%), pancreas cancer (18%), neuroendocrine tumors (14%), chronic pancreatitis (24%), other benign disease (22%) and in Korea, in contrast, disease caused by inflammatory process such as chronic pancreatitis has had relatively low incidence. But the rate of combined resection of distal pancreas at the time of gastric surgery was relatively high.

Definitions and names of pancreatic fistula have been reported differently in each center. Heidelberg and Johns Hopkins groups defined pancreatic fistula as drain amylase levels more than three times of normal serum value , and with more than 50mL during 24 hours after postoperative 10 days. German and Italian groups defined that as drain amylase levels more than three times of normal serum value, and with more than 10mL during 24 hours after postoperative 3-4 days. Japanese group defined pancreatic fistula as drain amylase levels more than three times of normal serum value, and with persistent drainage after postoperative 7 days. Lowy et al defined clinically significant pancreatic fistula as 38℃ or more of fever and leukocytosis (> 10,000 cells/mm3), and sepsis associated or necessity of drainage of abdominal fluid.

To adjust this various criteria, International Study Group Pancrea
Sponsor: Seoul National University Hospital

Current Primary Outcome: The rate of pancreatic fistula between groups [ Time Frame: postoperative 3rd day ]

Pancreatic fistula was defined by criterion of ISGPF, Output through an operatively placed drain or a subsequently placed percutaneous drain, of any measurable volume of drain fluid on or after postoperative day 3, with an amylase content greater than three times the upper normal serum value


Original Primary Outcome: The rate of pancreatic fistula between groups [ Time Frame: postoperative 3rd day ]

Pancreatic fistula was defined by criterior of ISGPF, Output through an operativerly placed drain or a subsequently placed percutaneous drain, of any measurable volume of drain fluid on or after postoperative day 3, with an amylase content greater than three times the upper normal serum value


Current Secondary Outcome:

  • Surgery-related risk factor [ Time Frame: intraoperative time ]
    Amount of intraoperative bleeding, blood transfusion, operative time, operative method with open, laparoscopic, or robotic surgery
  • disease- associated factors [ Time Frame: intraoperative time, within 1 day after operation ]
    pancreatic hardness, pathological findings, diameter of main p- duct, and the thickness of pancreas resection area
  • patient-related risk factors analysis [ Time Frame: 1 week before the operation ]
    age, sex, race, comorbidity


Original Secondary Outcome: Same as current

Information By: Seoul National University Hospital

Dates:
Date Received: November 21, 2011
Date Started: November 2011
Date Completion:
Last Updated: June 6, 2016
Last Verified: June 2016