COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01550406
Recruitment Status : Completed
First Posted : March 12, 2012
Last Update Posted : June 8, 2016
Information provided by (Responsible Party):
Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Pancreatic Fistula Device: Tachocomb Device: Polyglycolic acid (PGA) (Neoveil) Phase 4

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Use of Polyethylene Glycolic Acid or Tachocomb to Prevent Pancreatic Fistula Following Distal Pancreatectomy: Prospective Multicenter Randomized Study
Study Start Date : November 2011
Actual Primary Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas
Drug Information available for: TachoComb

Arm Intervention/treatment
Active Comparator: Tachocomb
Tachocomb will be applicated on the cut surface of distal pancreatectomy
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

Active Comparator: PGA
PGA will be applicated on the cut surface of distal pancreatectomy
Device: Polyglycolic acid (PGA) (Neoveil)
Polyglycolide or Polyglycolic acid (PGA) is a biodegradable, thermoplastic polymer and the simplest linear, aliphatic polyester.
Other Name: Neoveil

No Intervention: Control
No mesh will be applicated on the cut surface of distal pancreatectomy

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Surgery-related risk factor [ Time Frame: intraoperative time ]
    Amount of intraoperative bleeding, blood transfusion, operative time, operative method with open, laparoscopic, or robotic surgery

  2. 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

  3. patient-related risk factors analysis [ Time Frame: 1 week before the operation ]
    age, sex, race, comorbidity

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   20 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01550406

Layout table for location information
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Bundang-gu, Korea, Republic of, 463-707
Department of Surgery, Seoul National University College of Medicine
Seoul, Korea, Republic of, 110-744
Severance Hospital
Seoul, Korea, Republic of, 120-752
Samsung Medical Center
Seoul, Korea, Republic of, 130-710
Gangnam Severance Hospital
Seoul, Korea, Republic of, 135-720
Sponsors and Collaborators
Seoul National University Hospital
Layout table for investigator information
Study Chair: Jin- Young Jang, M.D. Seoul National University Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Seoul National University Hospital Identifier: NCT01550406    
Other Study ID Numbers: PFDP-2011
First Posted: March 12, 2012    Key Record Dates
Last Update Posted: June 8, 2016
Last Verified: June 2016
Keywords provided by Seoul National University Hospital:
Pancreatic fistula
distal Pancreatectomy
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Fistula
Pathological Conditions, Anatomical
Digestive System Fistula
Digestive System Diseases
Pancreatic Diseases