臨床研究等提出・公開システム

Date of registration	May. 21, 2026
Last modified on	June. 10, 2026
Trial ID	jRCT1061260023

Scientific Title	Efficacy of peripheral parenteral nutrition solution on outcomes in robotic pancreatoduodenectomy: A randomized controlled trial
Public Title	Efficacy of peripheral parenteral nutrition solution on outcomes in robotic pancreatoduodenectomy

Contact for Scientific Queries	Name	Takagi Kosei
	Affiliation	Okayama University Hospital
	Address	2-5-1 shikatacho, Kita-ku, Okayama City
	Telephone	+81-86-235-7257
	E-mail	kosei0913@gmail.com
Contact for Public Queries	Name	Takagi Kosei
	Affiliation	Okayama University Hospital
	Address	2-5-1 shikatacho, Kita-ku, Okayama City
	Telephone	+81-86-235-7257
	E-mail	kosei0913@gmail.com

Recruitment status	Recruiting

Anticipated date of first enrollment		May. 21, 2026
Actual date of first enrollment		June. 08, 2026
Target sample size		56
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1.Age is 18 years or older 2.The patients who receive robotic pancreatoduodenectomy at our institution 3. Patients who have given written informed consent
	Exclusion Criteria	1. patients who cannot give consent 2. severe respiratory dysfunction (arterial PaO2 <70 mmHg) 3. severe cardiac dysfunction (New York Heart Association 3 or more) 4. severe hepatic dysfunction (Child Pugh classification C) 5. severe renal dysfunction (hemodialysis) 6. acute bacterial infections 7. severe psychiatric disorder 8. patients with distant metastases 9. palliative surgery 10. emergency surgery 11. investigator not available
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		The patients who require robotic pancreatoduodenectomy
Intervention(s)		For postoperative fluid therapy, peripheral parenteral nutrition solution will be used; 2200ml per a day from postoprative day 1. The dosage can be adjusted according to the amount of oral intake.
Primary Outcome(s)		Body weight loss rate on postoperative 1 month compared t admission
Secondary Outcome(s)		Muscle mass reduction rate before discharge Body composition changes before discharge Changes of skeletal muscle mass, weight loss rate, body composition on postoperative 1 month Nutrition-related blood index (TP, Alb, pre-Alb, T-Chol, lymphocyte count, CRP) Inflammatory reaction increased (postoperative maximum values of WBC and CRP) Postoperative outcomes (length of hospital stay, complications, etc) Postoperative liver and renal dysfunction (AST, ALT, T-Bil, BUN, Cr) Postoperative QOL evaluation (PGSAS-45) peripheral parenteral nutrition solution dosage during observation period

Secondary Sponsor

Secondary Sponsor

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Okayama University Certified Review Board
Address	2-5-1 Shikata-cho, Kita-ku, Okayama city, Okayama
Telephone	+81-86-235-6503
E-Mail	ouh-crrb@adm.okayama-u.ac.jp
Approval Status	Approval
Date of approval	May. 13, 2026

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	June. 10, 2026	(this page)	Changes
1	May. 21, 2026	Detail

List of change history