Predictive risk factors for pancreatic fistula grade C after pancreaticoduodenectomy: prospective large observational study

Predictive risk factors for pancreatic fistula grade C after pancreaticoduodenectomy: prospective large observational study - Predictive risk factors for pancreatic fistula grade C after pancreaticoduodenectomy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000015942

Enrollment

3000

Registered

2014-12-14

Start date

2014-12-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients who undergo pancreaticoduodenectomy for pancreatic or periampullary lesions

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 5) patients requiring resection of other organs during pancreaticoduodenectomy

Design outcomes

Primary

Measure	Time frame
To clarify the predictive risk factors to develop pancreatic fistula grade C by ISGPF classification	—

Secondary

Measure	Time frame
* To clarify the predictive risk factors of overall pancreatic fistula (grade A, grade B and grade C) * To clarify the predictive risk factors of clinical relevant pancreatic fistula (grade B and grade C) * To clarify the predictive risk factors for postpancreatecomy hemorrhage(PPH) * cut-off value of drain amylase fluid on POD1 to distinguish pancreatic fistula grade C with grade A and grade B * cut-off value of drain amylase fluid on POD1 to distinguish pancreatic fistula grade B and C with grade A * morbidity * 30-day mortality * 90-day mortality	—

Measure

Time frame

* To clarify the predictive risk factors of overall pancreatic fistula (grade A, grade B and grade C) * To clarify the predictive risk factors of clinical relevant pancreatic fistula (grade B and grade C) * To clarify the predictive risk factors for postpancreatecomy hemorrhage(PPH) * cut-off value of drain amylase fluid on POD1 to distinguish pancreatic fistula grade C with grade A and grade B * cut-off value of drain amylase fluid on POD1 to distinguish pancreatic fistula grade B and C with grade A * morbidity * 30-day mortality * 90-day mortality

—

Countries

Japan,Asia(except Japan)

Contacts

Public ContactSeiko Hirono

Wakayama Medical University Second Department of Surgery

seiko-h@wakayama-med.ac.jp073-441-0613

Outcome results