Predictive Risk Factors for Pancreatic Fistula Grade C After Pancreaticoduodenectomy

Disease of Pancreatic Head or Periampullary Lesions to Require Pancreaticoduodenectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02322424
• Other study ID #: Japan-Taiwan PD Project
• Status: Recruiting
• Phase: N/A
• First received: December 17, 2014
• Last updated: December 17, 2014
• Start date: December 2014
• Est. completion date: June 2017

Study information

• Verified date: December 2014
• Source: Wakayama Medical University
• Contact: Hiroki Yamaue, M.D., PhD.
• Phone: +81-73-441-0613
• Email: yamaue-h[@]wakayama-med.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Disease of Pancreatic Head or Periampullary Lesions to Require Pancreaticoduodenectomy
• Pancreatic Fistula

Intervention

Procedure:
• pancreaticoduodenectomy

Locations

Country	Name	City	State
Taiwan	Chang Gun Memorial Hospital	Linkou

Sponsors (1)

Lead Sponsor	Collaborator
Wakayama Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of pancreatic fistula grade C		90 days after pancreaticoduodenectomy	No
Secondary	Incidence of overall pancreatic fistula (grade A, grade B and grade C)		90 days after pancreaticoduodenectomy	No
Secondary	Incidence of clinical relevant pancreatic fistula (grade B and grade C)		90 days after pancreaticoduodenectomy	No
Secondary	Incidence of postpancreatecomy hemorrhage(PPH)		90 days after pancreaticoduodenectomy	No
Secondary	Cut-off value of drain amylase fluid on POD1 to distinguish pancreatic fistula grade C with grade A and grade B		90 days after pancreaticoduodenectomy	No
Secondary	Cut-off value of drain amylase fluid on POD1 to distinguish pancreatic fistula grade B and C with grade A		90 days after pancreaticoduodenectomy	No
Secondary	Morbidity		90 days after pancreaticoduodenectomy	No
Secondary	30-day mortality		30 days after pancreaticoduodenectomy	No
Secondary	90-day mortality		90 days after pancreaticoduodenectomy	No