UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of preoperative nutritional intervention in patients who underwent pancreaticoduodenectomy
Title of the study (Brief title)	Study of preoperative nutritional intervention in patients who underwent pancreaticoduodenectomy
Region	Japan

Condition
Condition	pancreaticoduodenal carcinoma (pancreatic tumor, distal cholangiocarcinoma, ampullary carcinoma)
Classification by specialty	Surgery in general Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the fast postoperative recovery and reduction of postoperative complications by preoperative nutrition support and shortening of preoperative fasting period in patients undergoing pancreaticoduodenectomy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the postoperative complications rate
Key secondary outcomes	first-year recurrence free survival, body weight, serum albumin, total lymphocyte count, total cholesterol, cholinesterase, CRP, HbA1c, insulin dose (if the patient use insulin injection)

Base
Study type

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Food
Interventions/Control_1	Intake of Elental(R) from 7-10 days before operation to the day before operation and oral carbohydrate-containing fluid in the operation day
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	20 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	(1)Patients with pancreaticoduodenal tumor (pancreatic tumor, bile duct tumor, ampullary tumor) (2)Patients who will undergo Pancreaticoduodenectomy (3)Performance status: 0-2 (4)Patients who fully understand the study procedures and consent the document voluntary after an adequate explanation (5)Patients who underwent pancreaticoduodenectomy before this study running (control arm)
Key exclusion criteria	(1) sever diabetes mellitus, disorder of carbohydrate metabolism due to high dose steroid (2) disorder of amino acid metabolism (3) allergy to Elental(R) (4) Patients who are pregnant or hope to be pregnant (5) Patients who offer discontinuation of the study (6) Patients who are judged as inadequate to participate the study by the their doctors
Target sample size	60

Research contact person
Name of lead principal investigator	Osamu Itano
Organization	Keio University School of Medicine
Division name	Department of Surgery
Address	Shinanomachi 35, shinjuku-ku
TEL	03-3353-1211(ext62529)
Email	contact@keio-hbpts.jp

Public contact
Name of contact person	Minoru Kitago
Organization	Keio University School of Medicine
Division name	Department of Surgery
Address	Shinanomachi 35, shinjuku-ku
TEL	03-3353-1211(ext62529)
Homepage URL
Email	contact@keio-hbpts.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	Non
Organization
Division
Category of Funding Organization	Self funding
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	慶応義塾大学病院

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 19 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 08 Month 01 Day
Anticipated trial start date	2013 Year 08 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	2014 Year 08 Month 18 Day
Last modified on	2017 Year 10 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016760