Predictive Risk Factors for Pancreatic Fistula Grade C After Pancreaticoduodenectomy

• Conditions: Disease of Pancreatic Head or Periampullary Lesions to Require Pancreaticoduodenectomy
• Interventions: Procedure: pancreaticoduodenectomy

• Registration Number: NCT02322424
• Lead Sponsor: Wakayama Medical University

Brief 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.

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 Timeline

• Status Verified: 2014-12
• Study Start: 2014-12
• Study First Submitted: 2014-12-17
• Study First Submitted QC: 2014-12-17
• Last Update Submitted: 2014-12-17
• Study First Posted: 2014-12-23
• Last Update Posted: 2014-12-23
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients who undergo pancreaticoduodenectomy	pancreaticoduodenectomy	-

Primary Outcome Measures

Name	Time	Method
Incidence of pancreatic fistula grade C	90 days after pancreaticoduodenectomy

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chang Gun Memorial Hospital; 🇨🇳 Linkou, Taiwan