UMIN-CTR Clinical Trial

Basic information
Public title	The impact of pancreatic duct stent in pancreatic fistula following pancreaticoduodenectomy;retrospective large observational study by Japan-Korean project
Acronym	The impact of pancreatic duct stent in pancreatic fistula after pancreaticoduodenectomy
Scientific Title	The impact of pancreatic duct stent in pancreatic fistula following pancreaticoduodenectomy;retrospective large observational study by Japan-Korean project
Scientific Title:Acronym	The impact of pancreatic duct stent in pancreatic fistula after pancreaticoduodenectomy
Region	Japan Asia(except Japan)

Condition
Condition	patients who underwent pancreaticoduodenectomy for periampullary lesion
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this multicenter large cohort study was to clarify which pancreatic stent is more effective between internal stent and external stent to reduce clinically relevant pancreatic fistula after pancreaticoduodenectomy (PD).
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The incidence of pancreatic fistula classified by the International Study Group of Pancreatic Fistula(ISGPF) between internal stent and external stent
Key secondary outcomes

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
Key exclusion criteria	patients who are unfit for this study as determined by the attending physician
Target sample size	3000

Research contact person
Name of lead principal investigator	1st name Manabu Middle name Last name Kawai
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Zip code	641-8510
Address	811-1 Kimiidera, Wakayama, Japan, 641-8510
TEL	073-441-0613
Email	kawai@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Manabu Middle name Last name Kawai
Organization	Second Department of Surgery, Wakayama Medical University
Division name	Second Department of Surgery
Zip code	641-8510
Address	811-1 Kimiidera, Wakayama, Japan, 641-8510
TEL	0734410613
Homepage URL
Email	kawai@wakayama-med.ac.jp

Sponsor
Institute	Second Department of Surgery, Wakayama Medical University
Institute
Department

Funding Source
Organization	Japanese Society of Hepato-Biliary-Pancreatic Surgery
Organization
Division
Category of Funding Organization	Other
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 Kimiidera, Wakayama, Japan, 641-8510
Tel	073-447-2300
Email	wa-rinri@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	2018 Year 04 Month 30 Day

Related information
URL releasing protocol	https://wakayama-med-2ndsurg.jp/news/
Publication of results	Published

Result
URL related to results and publications	https://wakayama-med-2ndsurg.jp/news/
Number of participants that the trial has enrolled	3149
Results	clinically relevant pancreatic fistula occurred in more patients in the external stents group (280 patients, 28.7%) than in patients in the internal stents group (126 patients, 12.9%) (OR 2.713 [95% CI, 2.139e3.455]; P < 0.001).
Results date posted	2021 Year 01 Month 07 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	3149 patients who underwent　PD at 20 institutions in Japan and Korea between 2007 and 2013.
Participant flow	End of follow-up
Adverse events	none
Outcome measures	The primary endpoint was the incidence of clinically relevant pancreatic fistula
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 09 Day
Date of IRB	2015 Year 02 Month 09 Day
Anticipated trial start date	2015 Year 02 Month 09 Day
Last follow-up date	2018 Year 07 Month 30 Day
Date of closure to data entry	2018 Year 10 Month 30 Day
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information	Between 2007 and 2013, 3,149 patients (internal stent and external stent) who underwent PD at 20 institutions in Japan and Korea are reviewed. Propensity score matched analysis is used to minimize bias from nonrandomized treatment assignment. The primary endpoint was the incidence of clinically relevant pancreatic fistula based on the International Study Group on Pancreatic Fistula criteria.

Management information
Registered date	2018 Year 04 Month 27 Day
Last modified on	2021 Year 01 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036954