UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective randomized controlled trial comparing isolated Roux-en-Y reconstruction with Billroth-II-type reconstruction after pancreaticoduodenectomy
Title of the study (Brief title)	Evaluation of isolated Roux-en-Y reconstruction after pancreaticoduodenectomy
Region	Japan

Condition
Condition	pancreatic cancer, biliary cancer, duodenal cancer, pancreatic tumor, biliary tumor,duodenal tumor
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the incidence of complications with the isolated Roux-en-Y reconstruction after pancreaticoduodenectomy in pancreatic tumor and periampullary tumor patients. A prospective randomized controlled trial was conducted to compare the incidence of complications with isolated Roux-en-Y reconstruction with those of Billroth-II-type reconstruction after pancreaticoduodenectomy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	pancratic fistula
Key secondary outcomes	the incidence of other postoperative complications, mortality, delayed ggastric emptying, intra-abdominal hemorrhage, and intra-abdominal abscess.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Reconstruction after pancreaticoduodenectomy with Billroth-II-type
Interventions/Control_2	Reconstruction after pancreaticoduodenectomy with isolated Roux-en-Y
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with pancreatico-biliary disease who were performed pancreaticoduodenectomy at Wakayama Medical University Hospital
Key exclusion criteria	1) young patients (less than 20-year-old), 2) patients with severe complications which were possible to prolong hospital stay, 3) patients undergone hemodialysis, 4) patients combined resection of other organs, 5) patients who were diagnosed inadequacy for this study by a physician, and 6) patients without an informed consent
Target sample size	150

Research contact person
Name of lead principal investigator	Masaji Tani
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Address	811-1 Kimiidera, Wakayama
TEL	073-447-2300
Email	matani@wakayama-med.ac.jp

Public contact
Name of contact person	Masaji Tani
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Address	811-1 Kimiidera, Wakayama
TEL	073-447-2300
Homepage URL
Email	srg2@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Wakayama Medical University
Organization
Division
Category of Funding Organization	Other
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	2009 Year 05 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 04 Month 24 Day
Anticipated trial start date	2009 Year 05 Month 01 Day
Last follow-up date	2014 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2009 Year 05 Month 13 Day
Last modified on	2016 Year 07 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002402