Enteral versus parental nutrition after pancreaticoduodenectomy under enhanced recovery after surgery management; protocol for a multicenter, open-label randomized controlled trial
Phase 4
Recruiting
- Conditions
- Patients undergoing pancreaticoduodenectomy
- Registration Number
- JPRN-jRCT1030210691
- Lead Sponsor
- Saiura Akio
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 320
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Infectious complication
- Secondary Outcome Measures
Name Time Method 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.