UMIN-CTR Clinical Trial

Basic information
Public title	The prospective study for the pediatirc endoscopic operations which are not published by a fee-for service list
Acronym	The prospective study for the pediatirc endoscopic operations which are not published by a fee-for service list
Scientific Title	The prospective study for the pediatirc endoscopic operations which are not published by a fee-for service list
Scientific Title:Acronym	The prospective study for the pediatirc endoscopic operations which are not published by a fee-for service list
Region	Japan

Condition
Condition	esophageal atresia, esophageal stenosis , pleuroperitoneal hiatus hernia, acute or chronic renal failure, omental cyst or mesenterium cystoma, choledochal cyst, biliary atresia, pancreas tumor, pancreas head region tumor, acute or chronic pancreatitis, pancreatic lithiasis, intussusception, hypersplenism, splenic injury, sacrococcygeal teratoma, vesicoureteral reflux
Classification by specialty	Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery Vascular surgery Chest surgery Endocrine surgery Child
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The prospective study for safety and efficacy of the pediatirc endoscopic operations which are not published by a fee-for service list
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1)operative time, 2)operative blood loss, 3)open conversion, 4)intra-, post-operative complication, 5)reoperation, 6)post-operative length of stay, 7)surgery-related death, 8)long-term outcome
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	the pediatric endoscopic operations which are not published by a fee-for-service list
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	1.diseases targeted for this study 2.operative treatment is generally proven as an effective treatment 3.A written informed consent is obtained in this study 4.exception to exclusion criterion
Key exclusion criteria	1.no consent for this study 2.in case we judge the endoscopic operation could not be applied
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroo Uchida
Organization	Department of Pediatric Surgery, Nagoya University Graduate School of Medicine
Division name	Pediatric Surgery
Zip code
Address	65 Tsurumai-cho,Showa-ku, Nagoya,Japan
TEL	052-744-2959
Email	hiro2013@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hiroo Uchida
Organization	Department of Pediatric Surgery, Nagoya University Graduate School of Medicine
Division name	Pediatric of Surgery
Zip code
Address	65 Tsurumai-cho,Showa-ku, Nagoya,Japan
TEL	052-744-2959
Homepage URL
Email	hiro2013@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Nagoya University Graduate School of Medicine
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
Address
Tel
Email

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	名古屋大学　医学部　附属病院　（愛知県）

Other administrative information
Date of disclosure of the study information	2015 Year 04 Month 01 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	Completed
Date of protocol fixation	2015 Year 03 Month 01 Day
Date of IRB	2015 Year 05 Month 07 Day
Anticipated trial start date	2015 Year 05 Month 08 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 12 Month 31 Day
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded	2021 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2015 Year 03 Month 31 Day
Last modified on	2021 Year 10 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019025