UMIN-CTR Clinical Trial

Basic information
Public title	Predictive risk factors for pancreatic fistula grade C after pancreaticoduodenectomy: prospective large observational study
Acronym	Predictive risk factors for pancreatic fistula grade C after pancreaticoduodenectomy
Scientific Title	Predictive risk factors for pancreatic fistula grade C after pancreaticoduodenectomy: prospective large observational study
Scientific Title:Acronym	Predictive risk factors for pancreatic fistula grade C after pancreaticoduodenectomy
Region	Japan Asia(except Japan)

Condition
Condition	Patients who undergo pancreaticoduodenectomy for pancreatic or periampullary lesions
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of the present study is to clarify the risk factors for pancreatic fistula grade C
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	To clarify the predictive risk factors to develop pancreatic fistula grade C by ISGPF classification
Key secondary outcomes	* 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

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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
Key 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
Target sample size	3000

Research contact person
Name of lead principal investigator	1st name Hiroki Middle name Last name Yamaue
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Zip code	641-8510
Address	811-1 Kimiidera, Wakayama, Japan
TEL	0734410613
Email	seiko-h@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Seiko Middle name Last name Hirono
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Zip code	6418510
Address	811-1 Kimiidera, Wakayama, Japan
TEL	073-441-0613
Homepage URL
Email	seiko-h@wakayama-med.ac.jp

Sponsor
Institute	Japanese Society of Hepato-Biliary-Pancreatic Surgery
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Wakayama Medical University
Address	811-1 Wakayama Medical University
Tel	0734410613
Email	seiko-h@wakayama-med.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 14 Day

Related information
URL releasing protocol	None
Publication of results	Published

Result
URL related to results and publications	doi: 10.1002/jhbp.799. Epub 2020 Aug 6
Number of participants that the trial has enrolled	3022
Results	Among 2762 patients, 46 patients (1.7%) developed Grade C POPF after PD. The mortality rate of the 46 patients with Grade C POPF was 37.0%. On the multivariate analysis, six independent risk factors for Grade C POPF were found; BMI > 25.0 kg/m2 , chronic steroid use, preoperative serum albumin <3.0 mg/dL, soft pancreas, operative time >480 minutes, and intraoperative transfusion. The c-statistic of our risk scoring model for Grade C POPF using these risk factors was 0.77.
Results date posted	2021 Year 06 Month 19 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Patients who undergo pancreatoduodenectomy
Participant flow	3022 patients were enrolled in this study and 2762 patients were analyzed.
Adverse events	None
Outcome measures	Risk factors associated with grade C postoperative pancreatic fistula
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 11 Month 21 Day
Date of IRB	2014 Year 11 Month 01 Day
Anticipated trial start date	2014 Year 12 Month 10 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Study design: prospective observational study Target number of subjects: 3,000 patients Study period: 3 years and 6 months Registration period: 3 years Subjects: Patients who undergo pancreaticoduodenectomy for pancreatic or periampullary lesions in Japan and Taiwan Primary endpoint: To clarify the predictive risk factors to develop pancreatic fistula grade C by ISGPF classification Secondary endpoints: 1) To clarify the predictive risk factors of overall pancreatic fistula (grade A, B and C) 2) To clarify the predictive risk factors of clinical relevant pancreatic fistula (grade B and C) 3) To clarify the predictive risk factors for postpancreatecomy hemorrhage 4) Cut-off value of drain amylase fluid on POD1 to distinguish pancreatic fistula grade C with grade A and B 5) Cut-off value of drain amylase fluid on POD1 to distinguish pancreatic fistula grade B and C with grade A 6) morbidity 7) 30-day mortality 8) 90-day mortality

Management information
Registered date	2014 Year 12 Month 14 Day
Last modified on	2021 Year 06 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018550