NCT01550406

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 12, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Last Updated

June 8, 2016

Status Verified

June 1, 2016

Enrollment Period

3.4 years

First QC Date

November 21, 2011

Last Update Submit

June 6, 2016

Conditions

Pancreatic Fistula

Keywords

Pancreatic fistuladistal Pancreatectomy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Surgery-related risk factor

    intraoperative time

  • disease- associated factors

    intraoperative time, within 1 day after operation

  • patient-related risk factors analysis

    1 week before the operation

Study Arms (3)

Tachocomb

ACTIVE COMPARATOR

Tachocomb will be applicated on the cut surface of distal pancreatectomy

Device: Tachocomb

PGA

ACTIVE COMPARATOR

PGA will be applicated on the cut surface of distal pancreatectomy

Device: Polyglycolic acid (PGA) (Neoveil)

Control

NO INTERVENTION

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

Interventions

TachocombDEVICE

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

Tachocomb
Polyglycolic acid (PGA) (Neoveil)DEVICE

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

Also known as: Neoveil
PGA

Eligibility Criteria

Age20 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Seoul National University Bundang Hospital

Seongnam, Bundang-gu, 463-707, South Korea

Location

Department of Surgery, Seoul National University College of Medicine

Seoul, 110-744, South Korea

Location

Severance Hospital

Seoul, 120-752, South Korea

Location

Samsung Medical Center

Seoul, 130-710, South Korea

Location

Gangnam Severance Hospital

Seoul, 135-720, South Korea

Location

Related Publications (2)

  • Jang JY, Shin YC, Han Y, Park JS, Han HS, Hwang HK, Yoon DS, Kim JK, Yoon YS, Hwang DW, Kang CM, Lee WJ, Heo JS, Kang MJ, Chang YR, Chang J, Jung W, Kim SW. Effect of Polyglycolic Acid Mesh for Prevention of Pancreatic Fistula Following Distal Pancreatectomy: A Randomized Clinical Trial. JAMA Surg. 2017 Feb 1;152(2):150-155. doi: 10.1001/jamasurg.2016.3644.

    PMID: 27784046DERIVED

  • Park JS, Lee DH, Jang JY, Han Y, Yoon DS, Kim JK, Han HS, Yoon Y, Hwang D, Kang CM, Hwang HK, Lee WJ, Heo J, Chang YR, Kang MJ, Shin YC, Chang J, Kim H, Jung W, Kim SW. Use of TachoSil((R)) patches to prevent pancreatic leaks after distal pancreatectomy: a prospective, multicenter, randomized controlled study. J Hepatobiliary Pancreat Sci. 2016 Feb;23(2):110-7. doi: 10.1002/jhbp.310. Epub 2016 Jan 19.

    PMID: 26681272DERIVED

MeSH Terms

Conditions

Pancreatic Fistula

Condition Hierarchy (Ancestors)

Digestive System FistulaDigestive System DiseasesPancreatic DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Jin- Young Jang, M.D.

    Seoul National University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2011

First Posted

March 12, 2012

Study Start

November 1, 2011

Primary Completion

April 1, 2015

Last Updated

June 8, 2016

Record last verified: 2016-06

Locations

KR(5)