UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014887
Receipt number R000016760
Scientific Title Study of preoperative nutritional intervention in patients who underwent pancreaticoduodenectomy
Date of disclosure of the study information 2014/08/19
Last modified on 2017/10/14 19:28:39

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Basic information

Public title

Study of preoperative nutritional intervention in patients who underwent pancreaticoduodenectomy

Acronym

Study of preoperative nutritional intervention in patients who underwent pancreaticoduodenectomy

Scientific Title

Study of preoperative nutritional intervention in patients who underwent pancreaticoduodenectomy

Scientific Title:Acronym

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

1st name
Middle name
Last name Osamu Itano

Organization

Keio University School of Medicine

Division name

Department of Surgery

Zip code


Address

Shinanomachi 35, shinjuku-ku

TEL

03-3353-1211(ext62529)

Email

contact@keio-hbpts.jp


Public contact

Name of contact person

1st name
Middle name
Last name Minoru Kitago

Organization

Keio University School of Medicine

Division name

Department of Surgery

Zip code


Address

Shinanomachi 35, shinjuku-ku

TEL

03-3353-1211(ext62529)

Homepage URL


Email

contact@keio-hbpts.jp


Sponsor or person

Institute

Keio University School of Medicine

Institute

Department

Personal name



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)



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

慶応義塾大学病院


Other administrative information

Date of disclosure of the study information

2014 Year 08 Month 19 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

No longer recruiting

Date of protocol fixation

2013 Year 08 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016760


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name