Predictive Risk Factors for Pancreatic Fistula Grade C After Pancreaticoduodenectomy

December 17, 2014 updated by: Hiroki Yamaue, Wakayama Medical University

Predictive Risk Factors for Pancreatic Fistula Grade C After Pancreaticoduodenectomy: Prospective Large Observational Study

Pancreatic fistula (PF) grade C, defined by the International Study Group of Pancreatic Fistula (ISGPF) is associated with a life-threatening complication after pancreaticoduodenectomy(PD). Therefore, The aim of this study is to clarify the risk factors for grade C PF by Japan and Taiwan cooperative project.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Pancreatic fistula (PF) grade C, defined by the International Study Group of Pancreatic Fistula (ISGPF) is associated with a life-threatening complication after pancreaticoduodenectomy(PD). The rate of grade C PF has been reported 2.5-6%, however, it is critical complication after PD. A large number of enrolled patients will be needed to clarify the risk factors for grade C PF. Therefore, this study design is prospective large observational study at multi-center in Japan and Taiwan.

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Linkou, Taiwan
        • Recruiting
        • Chang Gun Memorial Hospital
        • Contact:
          • Tsann-Long Hwang, M.D., PhD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

3,000 patients who undergo pancreaticoduodenectomy (PD) in Japan and Taiwan

Description

Inclusion Criteria:

  1. Disease of pancreatic head or periampullary lesions to require pancreaticoduodenectomy
  2. Age: 20 years or older
  3. PS (ECOG performance status scale) 0-1 at the time of enrollment
  4. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  1. patients with severe respiratory disorder required oxygen inhalation
  2. patients with severe liver dysfunction
  3. patients with chronic renal failure with dialysis
  4. patients who are unfit for this study as determined by the attending physician

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients who undergo pancreaticoduodenectomy
Procedure: pancreaticoduodenectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of pancreatic fistula grade C
Time Frame: 90 days after pancreaticoduodenectomy
90 days after pancreaticoduodenectomy

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of overall pancreatic fistula (grade A, grade B and grade C)
Time Frame: 90 days after pancreaticoduodenectomy
90 days after pancreaticoduodenectomy
Incidence of clinical relevant pancreatic fistula (grade B and grade C)
Time Frame: 90 days after pancreaticoduodenectomy
90 days after pancreaticoduodenectomy
Incidence of postpancreatecomy hemorrhage(PPH)
Time Frame: 90 days after pancreaticoduodenectomy
90 days after pancreaticoduodenectomy
Cut-off value of drain amylase fluid on POD1 to distinguish pancreatic fistula grade C with grade A and grade B
Time Frame: 90 days after pancreaticoduodenectomy
90 days after pancreaticoduodenectomy
Cut-off value of drain amylase fluid on POD1 to distinguish pancreatic fistula grade B and C with grade A
Time Frame: 90 days after pancreaticoduodenectomy
90 days after pancreaticoduodenectomy
Morbidity
Time Frame: 90 days after pancreaticoduodenectomy
90 days after pancreaticoduodenectomy
30-day mortality
Time Frame: 30 days after pancreaticoduodenectomy
30 days after pancreaticoduodenectomy
90-day mortality
Time Frame: 90 days after pancreaticoduodenectomy
90 days after pancreaticoduodenectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wakayama Medical University

Investigators

  • Principal Investigator: Hiroki Yamaue, M.D., PhD., Wakayama Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

December 17, 2014

First Submitted That Met QC Criteria

December 17, 2014

First Posted (Estimate)

December 23, 2014

Study Record Updates

Last Update Posted (Estimate)

December 23, 2014

Last Update Submitted That Met QC Criteria

December 17, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Japan-Taiwan PD Project

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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