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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000007533
Date of registration:	30/03/2012
Prospective Registration:	Yes
Primary sponsor:	Shizuoka Cancer Center
Public title:	Explorative trial of suppression effect of preoperative enteral nutrition enrichied with Eicosapentaenoic Acid(EPA) for hypercytokinemia after pancreaticoduodenectomy :a double blinded and randomaized controlled trial
Scientific title:	Explorative trial of suppression effect of preoperative enteral nutrition enrichied with Eicosapentaenoic Acid(EPA) for hypercytokinemia after pancreaticoduodenectomy :a double blinded and randomaized controlled trial - Explorative trial of suppression effect of preoperative enteral nutrition enrichied with Eicosapentaenoic Acid(EPA) for hypercytokinemia after pancreaticoduodenectomy :a double blinded and randomaized controlled trial
Date of first enrolment:	2012/04/01
Target sample size:	24
Recruitment status:	Recruiting
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008885
Study type:	Interventional
Study design:	Parallel Randomized
Phase:	Not selected

Countries of recruitment
Japan

Contacts

Name:	Katsuhiko Uesaka
Address:	1007 Shimonagakubo Nagaizumityou Suntougun Shizuoka Japan Japan
Telephone:	0559895222
Email:
Affiliation:	Shizuoka Cancer Center Division of Hepato-Biliary-Pancreatic Surgery

Name:	Shuichi Aoki
Address:	1007 Shimonagakubo Nagaizumityou Suntougun Shizuoka Japan Japan
Telephone:	0559895222
Email:	shuichi1124@msn.com
Affiliation:	Shizuoka Cancer Center Division of Hepato-Biliary-Pancreatic Surgery

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: (1)With poor oral intake (2)With other nutrition therapy (3)Being immunocompromised status or receiving steroids (4)With uncontrolled diabetes mellitus (5)With inflammatory bowel disease (6)With bacterial or viral infection (7)With radiation therapy, chemotherapy or nutrition therapy before registration (8)With psychiatric disorder (9)Possibly pregnant

Age minimum: 20years-old
Age maximum: 80years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Patients to require pancreaticoduodenectomy

Intervention(s)

enteral nutrition enrichied with Eicosapentaenoic Acid(EPA)
enteral nutrition

Primary Outcome(s)

The serum IL-6 value before and after pancreaticoduodenectomy

Secondary Outcome(s)

The nutrition status after preoperative enteral nutrition enrichied with Eicosapentaenoic Acid(EPA) The cytokine level after pancreaticoduodenectomy CD4/CD8 T lymphocyte balance after pancreaticoduodenectomy The incidence of post-operative infectious complications The incidence of adverse event

Secondary ID(s)

Source(s) of Monetary Support

Pharma Valley Center

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date:
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

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