NCT01550406

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 84 Years
• Healthy volunteers: Not accepted

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 description

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 Pancreatic Fistula (ISGPF) 2005 defined pancreatic fistula as drain amylase levels more than three times of normal serum value at the time of postoperative 3 days, and divided severity by 3 category with A to C in accordance with clinical course. As followed previous studies, pancreatic fistula has been one of major postoperative complications (13-64%), which is leading cause of intra-abdominal infections, abscesses, septicemia, wound infection, postoperative bleeding, and malnutrition Risk factors related pancreas fistula have been presented as a disease- associated factors (pancreatic hardness, pathological findings, diameter of main p- duct, and the thickness of pancreas resection area), surgery-related factors (method of pancreas resection, intraoperative blood loss, operative time, blood transfusion during surgery), patient-related factors (age, sex, race, comorbidity) and the experience of surgeon, etc. Based on experience and observation of the above listed risk factors for pancreatic fistula, there has been rarely reported that the incidence of pancreatic fistula was markedly reduced by some kind of methods. As mentioned above, one of the risk factors of pancreatic fistula is operative method or technique. To date, there has been many methods suggested to reduce pancreatic fistula. For example, as dealing with pancreas cut surface, there has been several methods, such as, hand-sewn suture techniques, stapled closure, the use of fibrin glue, the use of mesh. But there are few evidence of superiority to the other methods. Recent retrospective studies suggested the usefulness of mesh that the incidence of pancreatic fistula with mesh (5.6-27%) was lower than without mesh (38.9\~42.0%). There are two kind of mesh to use surgical fields, that are PGA and tachocomb. Among that, the methods with PGA has been reported in a few retrospective study. Moreover, there are no report about the effectiveness with Tachocomb. The objective of this prospective multicenter randomized study is to clarify the proper method to reduce pancreatic fistula by PGA or tachocomb.

Conditions

• Pancreatic Fistula

Interventions

Type	Name	Description
DEVICE	Tachocomb	A kind of Mesh: ready-to-use hemostatic agent consisting of a collagen sheet coated on one side with human fibrinogen, bovine thrombin, and bovine aprotinin
DEVICE	Polyglycolic acid (PGA) (Neoveil)	Polyglycolide or Polyglycolic acid (PGA) is a biodegradable, thermoplastic polymer and the simplest linear, aliphatic polyester.

Timeline

• Start date: 2011-11-01
• Primary completion: 2015-04-01
• First posted: 2012-03-12
• Last updated: 2016-06-08

Locations

5 sites across 1 country: South Korea