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

Pancreatic Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01550406
• Other study ID #: PFDP-2011
• Status: Completed
• Phase: Phase 4
• First received: November 21, 2011
• Last updated: June 6, 2016
• Start date: November 2011

Study information

• Verified date: June 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 84 Years

Eligibility

Inclusion Criteria:

• Expected survival time more than 12 months

• Patients with at least one of the following pathologic diseases scheduled for elective resection

• Resectable malignancies of the pancreatic body/ tail

• Resectable pre-malignant lesions of the pancreatic body/ tail

• Resectable benign lesion of the pancreatic body/ tail

Exclusion Criteria:

• Current immunosuppressive therapy

• Pancreatic atrophy or calcification due to severe pancreatitis

• Chemotherapy or radiotherapy before operation

• Severe psychiatric or neurologic diseases

• Drug- and/or alcohol-abuse according to local standards

• Participation in another intervention trial with interference of a primary or secondary endpoint of this study

• Inability to follow the instructions given by the investigator

• Lack of compliance

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fistula
• Pancreatic Fistula

Intervention

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
• Polyglycolic acid (PGA) (Neoveil)
Polyglycolide or Polyglycolic acid (PGA) is a biodegradable, thermoplastic polymer and the simplest linear, aliphatic polyester.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Bundang-gu
Korea, Republic of	Department of Surgery, Seoul National University College of Medicine	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of pancreatic fistula between groups	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	postoperative 3rd day	No
Secondary	Surgery-related risk factor	Amount of intraoperative bleeding, blood transfusion, operative time, operative method with open, laparoscopic, or robotic surgery	intraoperative time	No
Secondary	disease- associated factors	pancreatic hardness, pathological findings, diameter of main p- duct, and the thickness of pancreas resection area	intraoperative time, within 1 day after operation	No
Secondary	patient-related risk factors analysis	age, sex, race, comorbidity	1 week before the operation	No