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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01550406
First received: November 21, 2011
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Pancreatic Fistula
Device: Tachocomb
Device: Polyglycolic acid (PGA) (Neoveil)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Use of Polyethylene Glycolic Acid or Tachocomb to Prevent Pancreatic Fistula Following Distal Pancreatectomy: Prospective Multicenter Randomized Study

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • The rate of pancreatic fistula between groups [ Time Frame: postoperative 3rd day ] [ Designated as safety issue: No ]
    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:
  • Surgery-related risk factor [ Time Frame: intraoperative time ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    age, sex, race, comorbidity


Estimated Enrollment: 150
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550406

Locations
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
Gangnam Severance Hospital
Seoul, Korea, Republic of, 135-720
Samsung Medical Center
Seoul, Korea, Republic of, 130-710
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Chair: Jin- Young Jang, M.D. Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01550406     History of Changes
Other Study ID Numbers: PFDP-2011
Study First Received: November 21, 2011
Last Updated: April 8, 2014
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by Seoul National University Hospital:
Pancreatic fistula
distal Pancreatectomy

Additional relevant MeSH terms:
Fistula
Pancreatic Fistula
Pathological Conditions, Anatomical
Digestive System Fistula
Digestive System Diseases
Pancreatic Diseases
Glycolic acid
Keratolytic Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014