UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A feasibility study of perioperative administration of immunoenhancing enteral nutrients combined with pancrelipase in patients with pancreatoduodenectomy for pancreatic cancer
Title of the study (Brief title)	A feasibility study of perioperative administration of immunoenhancing enteral nutrients combined with pancrelipase in patients with pancreatoduodenectomy for pancreatic cancer
Region	Japan

Condition
Condition	Pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the improvement of nutritional status and reduction of postoperative complications by ingestion of immunoenhancing enteral nutrients and pancrelipase in patients undergoing pancreaticoduodenectomy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Treatment completion rate of preoperative ingestion of immunoenhancing enteral nutrients and pancrelipase
Key secondary outcomes

Base
Study type	Interventional

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	1, Administration of immune-enhancing enteral nutrients from 2 weeks before surgery to 3 weeks after surgery. The dose of nutrients depends on the phase from 480kcal to 960kcal, 2. Administration of pancrelipase from postoperative day 1 to 21. The dose of pancrelipase is 1800mg per 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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients diagnosed with pancreatic cancer 2. Patients who will undergo Pancreaticoduodenectomy 3. ECOG-PS 0 or 1 4. Patients who can intake orally 5. Patients who fully understand the study procedures and consent the document voluntary after an adequate explanation
Key exclusion criteria	1. Patients with active double cancer 2. Patients who have active infection 3. Patients who need to restrict food or water intake 4. Patients with milk or soy allergy 5. Patients with pancrelipase allergy 6. Patients with pork protein allergy 7. Patients with ileus 8. Patients with advanced liver dysfunction or advanced renal dysfunction 9. Patients with abnormal glucose metabolism, such as severe diabetes 10. Patients with congenital disorders of amino acid metabolism 11. Patients with pregnancy 12. Patients who were deemed inappropriate for medical reasons
Target sample size	20

Research contact person
Name of lead principal investigator	Yasuhiro Kodera
Organization	Nagoya University, Graduate School of Medicine
Division name	Gastroenterorogical Surgery
Address	65 Tsurumai-cho Showa-ku Nagoya city
TEL	052-744-2253
Email	ykodera@med.nagoya-u.ac.jp

Public contact
Name of contact person	Suguru Yamada
Organization	Nagoya University, Graduate School of Medicine
Division name	Gastroenterorogical Surgery
Address	65 Tsurumai-cho Showa-ku Nagoya city
TEL	052-744-2253
Homepage URL
Email	suguru@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University, Graduate School of Medicine
Institute
Department

Funding Source
Organization	Nagoya University, Graduate School of Medicine
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	2017 Year 07 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 06 Month 01 Day
Anticipated trial start date	2017 Year 07 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	2017 Year 06 Month 04 Day
Last modified on	2018 Year 01 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031633