A Prospective, Randomized Trial of Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Yonsei University
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- To evaluate the impact of early postoperative enteral feeding
Study Overview
Brief Summary
Pancreaticoduodenectomy is associated with a high incidence of postoperative complications. These postoperative complications could delay postoperative resumption of adequate oral intake. Clinical study on postoperative feeding after pancreaticoduodenectomy is very limited. Method of Nutritional support (Enteral feeding or total parenteral support)after pancreaticoduodenectomy is controversial.
- To evaluate whether early enteral nutrition may be a suitable alternative to total parenteral nutrition
- To evaluate whether enteral feeding improve nutritional status after pancreaticoduodenectomy
Detailed Description
Pancreaticoduodenectomy is associated with a high incidence of postoperative complications. These postoperative complications could delay postoperative resumption of adequate oral intake. The use of TPN significantly increases postoperative complications, especially those associate with infections. However, method of Nutritional support (Enteral feeding or total parenteral support)after pancreaticoduodenectomy is controversial.
- To evaluate whether early enteral nutrition may be decreased the postoperative complications
- To evaluate whether enteral feeding improve nutritional status after pancreaticoduodenectomy
- To determine the optimal method for postoperative nutritional support
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Periampullar carcinoma
- •Pancreaticoduonectomy
- •KARNOFSKY PERFORMANCE SCALE > 70
- •No history of Major operation
Exclusion Criteria
- •Creatinine level>3mg/L
- •Ascitis/portal hypertension
- •New York Heart Association class>3
- •Preoperative Radiotheraly/chemotherapy
- •Unresectable primary cancer
- •Palliative surgery
Arms & Interventions
1
- Enteral Feeding
Intervention: Enteral Feeding and Total Parental Support (Procedure)
2
Total Parental support
Intervention: Enteral Feeding and Total Parental Support (Procedure)
Outcomes
Primary Outcomes
To evaluate the impact of early postoperative enteral feeding
Time Frame: Postoperative 21 days
Secondary Outcomes
- To evaluate the nutritional status(Postoperative 6 months)