UMIN-CTR Clinical Trial

Basic information
Public title	A prospective observational study of the onset of pancreaticojejunostomy stenosis and endoscopic treatment after pancreaticoduodenectomy
Acronym	A prospective observational study of the onset of pancreaticojejunostomy stenosis and endoscopic treatment after pancreaticoduodenectomy
Scientific Title	A prospective observational study of the onset of pancreaticojejunostomy stenosis and endoscopic treatment after pancreaticoduodenectomy
Scientific Title:Acronym	A prospective observational study of pancreaticojejunostomy stenosis and endoscopic treatment after PD
Region	Japan

Condition
Condition	Cases of pancreatoduodenectomy
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Surveillance of clinical course of pancreaticojejunostomy stenosis after pancreaticoduodenectomy
Basic objectives2	Others
Basic objectives -Others	Clinical outcomes of endoscopic treatment for pancreaticojejunostomy stenosis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence and time to onset of pancreaticojejunostomy stenosis
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Cases of pancreatoduodenectomy
Key exclusion criteria	None
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Kazuo Middle name Last name Hara
Organization	Aichi Cancer Center Hospital
Division name	Gastroenterology
Zip code	464-8681
Address	1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, Japan
TEL	0527626111
Email	khara@aichi-cc.jp

Public contact
Name of contact person	1st name Nozomi Middle name Last name Okuno
Organization	Aichi Cancer Center Hospital
Division name	Gastroenterology
Zip code	464-8681
Address	1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, Japan
TEL	0527626111
Homepage URL
Email	nokuno@aichi-cc.jp

Sponsor
Institute	Aichi Cancer Center Hospital
Institute
Department

Funding Source
Organization	Aichi Cancer Center Hospital
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	Aichi Cancer Center Hospital
Address	1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, Japan
Tel	0527626111
Email	irb-jimu@aichi-cc.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	20210146
Org. issuing International ID_1	Aichi Cancer Center Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 07 Month 20 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2022 Year 01 Month 20 Day
Date of IRB	2022 Year 01 Month 20 Day
Anticipated trial start date	2022 Year 01 Month 24 Day
Last follow-up date	2033 Year 01 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Registered cases will be followed up for 5 years after surgery. Add necessary information to the CRF (Case Report Form) every year after registration. Outcome surveys should be followed up as much as possible, and telephone surveys of patients and their families are also acceptable.

Management information
Registered date	2022 Year 07 Month 20 Day
Last modified on	2022 Year 07 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055179