JRCT ID: jRCT1061260023
Registered date:21/05/2026
Efficacy of peripheral parenteral nutrition solution on outcomes in robotic pancreatoduodenectomy
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | The patients who require robotic pancreatoduodenectomy |
| Date of first enrollment | 21/05/2026 |
| Target sample size | 56 |
| Countries of recruitment | |
| Study type | Interventional |
| 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. |
Outcome(s)
| Primary Outcome | Body weight loss rate on postoperative 1 month compared t admission |
|---|---|
| Secondary Outcome | 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 |
Key inclusion & exclusion criteria
| Age minimum | >= 18age old |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include 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 |
| Exclude 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 |
Related Information
| Primary Sponsor | Takagi Kosei |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Kosei Takagi |
| Address | 2-5-1 shikatacho, Kita-ku, Okayama City Okayama Japan 700-8558 |
| Telephone | +81-86-235-7257 |
| kosei0913@gmail.com | |
| Affiliation | Okayama University Hospital |
| Scientific contact | |
| Name | Kosei Takagi |
| Address | 2-5-1 shikatacho, Kita-ku, Okayama City Okayama Japan 700-8558 |
| Telephone | +81-86-235-7257 |
| kosei0913@gmail.com | |
| Affiliation | Okayama University Hospital |