UMIN-CTR Clinical Trial

Basic information
Public title	Comparison between antecolic and retrocolic gastrointestinal reconstruction in delayed gastric emptying after pancreaticoduodenectomy: A prospective randomized controlled multicenter trial.
Acronym	A prospective randomized controlled multicenter trial of delayed gastric emptying after pancreaticoduodenectomy evaluating by gastrointestinal reconstruction
Scientific Title	Comparison between antecolic and retrocolic gastrointestinal reconstruction in delayed gastric emptying after pancreaticoduodenectomy: A prospective randomized controlled multicenter trial.
Scientific Title:Acronym	A prospective randomized controlled multicenter trial of delayed gastric emptying after pancreaticoduodenectomy evaluating by gastrointestinal reconstruction
Region	Japan

Condition
Condition	Periampullary tumor
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the incidence of delayed gastric emptying in patient with pancreaticoduodenectomy between antecolic and retrocolic gastrointestinal reconstruction.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Incidence of delayed gastric emptying defined by ISGPS
Key secondary outcomes	Incidence of other postoperative morbidity.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Retrocolic gastro- or duodeno-jejunostomy in the pancreaticoduodenectomy
Interventions/Control_2	Antecolic gastro- or duodeno-jejunostomy in the pancreaticoduodenectomy
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	18 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with pancreatic-biliary disease who undergo pancreaticoduodenectomy
Key exclusion criteria	1)Patients who have the history of gastrectomy 2)Patients who have severe cardiorespiratory dysfunction 3)Patients who have liver cirrhosis or are receiving dialysis 4)Patients who were diagnosed inadequacy for this study by a physician
Target sample size	240

Research contact person
Name of lead principal investigator	1st name Yonson Middle name Last name Ku
Organization	Kobe University Graduate School of Medicine
Division name	Division of Hepato-Biliary Pancreatic Surgery, Department of Surgery
Zip code	6500017
Address	7-5-2 Kusunoki-Cho, Chuo-Ku, Kobe, Hyogo
TEL	078-382-6302
Email	yonson@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Hirochika Middle name Last name Toyama
Organization	Kobe University Graduate School of Medicine
Division name	Division of Hepato-Biliary Pancreatic Surgery, Department of Surgery
Zip code	6500017
Address	7-5-2 Kusunoki-Cho, Chuo-Ku, Kobe, Hyogo
TEL	078-382-6302
Homepage URL
Email	toyama@med.kobe-u.ac.jp

Sponsor
Institute	Division of Hepato-Biliary Pancreatic Surgery, Department of Surgery, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	none
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	kobe university
Address	kusunoki 7+5+2, Chuo-ku, Kobe, Japan
Tel	0783826302
Email	tymhr@me.com

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	2011 Year 09 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	2011 Year 06 Month 22 Day
Date of IRB	2011 Year 06 Month 22 Day
Anticipated trial start date	2011 Year 11 Month 01 Day
Last follow-up date	2016 Year 12 Month 01 Day
Date of closure to data entry	2017 Year 04 Month 01 Day
Date trial data considered complete	2017 Year 04 Month 01 Day
Date analysis concluded	2017 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date	2011 Year 06 Month 22 Day
Last modified on	2021 Year 06 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006833