UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Short and Long - Term Outcomes of Choledochojejunostomy during Pancreaticoduodenectomy and Total Pancreatectomy: Interrupted Suture versus Continuous Suture.
Title of the study (Brief title)	Short and Long - Term Outcomes of Choledochojejunostomy: Interrupted Suture versus Continuous Suture.
Region	Japan

Condition
Condition	The patients who underwent pancreaticoduodenectomy or total pancreatectomy at Osaka International Cancer Institute.
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the optimal method for choledochojejunostomy by comparing interrupted sutures and continuous sutures. Retrospective analyses using prospectively maintained clinical data base.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	short- and long- term complications related to choledochojejunostomy
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Choledochojejunostomy performed by interrupted sutures.
Interventions/Control_2	Choledochojejunostomy performed by continuous sutures
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	The patients who undewent pancreaticoduodenectomy or total pancreatectomy in Osaka International Cancer Institute.
Key exclusion criteria	The patients who required extensive resection of the bile duct are not eligible for this analysis.
Target sample size	200

Research contact person
Name of lead principal investigator	Hidenori Takahashi
Organization	Osaka International Cancer Institute
Division name	Department of Surgery
Address	3-1-69, Otemae, Chuo-ku, Osaka, 541-8567, JAPAN
TEL	06-6945-1181
Email	takahasi-hi@mc.pref.osaka.jp

Public contact
Name of contact person	Hidenori Takahashi
Organization	Osaka International Cancer Institute
Division name	Department of Surgery
Address	3-1-69, Otemae, Chuo-ku, Osaka, 541-8567, JAPAN
TEL	06-6945-1181
Homepage URL
Email	takahasi-hi@mc.pref.osaka.jp

Sponsor
Institute	Osaka International Cancer Institute
Institute
Department

Funding Source
Organization	The Osaka Foundation for The Prevention of Cancer and Life-style related Diseases
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

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 07 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 04 Month 01 Day
Anticipated trial start date	2007 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 07 Month 16 Day
Last modified on	2018 Year 07 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038079