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Enteral versus parental nutrition after pancreaticoduodenectomy under enhanced recovery after surgery management; protocol for a multicenter, open-label randomized controlled trial

Enteral versus parental nutrition after pancreaticoduodenectomy under enhanced recovery after surgery management; protocol for a multicenter, open-label randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1030210691
Enrollment
320
Registered
2022-03-23
Start date
2022-03-23
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing pancreaticoduodenectomy

Interventions

In the enteral nutrition group, enteral nutrition will start on postoperative day (POD) 1 at 200-300 ml/day via the percutaneous tube placed operatively. The volume of diet depends on the capacity per
enteral nutrition

Sponsors

Saiura Akio
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age equal to or above 20 years 2. Indication for elective PD 3. American society anesthesiologist performance score 1-3 4. Written informed consent by the patient

Exclusion criteria

Exclusion criteria: 1. Robot-assisted or laparoscopic PD 2. Combined liver resection 3. Antibiotic therapy within a week before surgery 4. Contraindication for EN (allergy, disorder of amino acid metabolism) 5. Severe cardiac, liver, or renal comorbidities 6. Inappropriate for enrollment based on the judgement of the investigator

Design outcomes

Primary

MeasureTime frame
Infectious complication

Secondary

MeasureTime frame
All postoperative complication, major complication (Clavien-Dindo grade >3), clinically-relevant postoperative pancreatic fistula, delayed gastric emptying, length of hospital stay, time to functional recovery, serum level of albumin, pre-albumin, transferin, cost, side effect, and the duration between surgery and introduction of adjuvant chemotherapy among patients with pancreatic cancer.

Contacts

Public ContactTakeda Yoshinori

Juntendo University Hospital

yo-takeda@juntendo.ac.jp+81-3-3813-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026