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Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy

A Prospective, Randomized Trial of Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00809081
Enrollment
38
Registered
2008-12-16
Start date
2007-07-31
Completion date
2010-01-31
Last updated
2008-12-16

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

Conditions

Ampulla of Vater Cancer, Bile Duct Cancer, Pancreas Cancer

Keywords

periampullar carcinoma, Pancreaticoduodenectomy, Enteral feeding, Total Parenteral Support

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. 1. To evaluate whether early enteral nutrition may be a suitable alternative to total parenteral nutrition 2. 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. 1. To evaluate whether early enteral nutrition may be decreased the postoperative complications 2. To evaluate whether enteral feeding improve nutritional status after pancreaticoduodenectomy 3. To determine the optimal method for postoperative nutritional support

Interventions

PROCEDUREEnteral Feeding and Total Parental Support

Enteral Feeding : 20ml/hr on POD1 * Velocity is progressively increased by 20ml/d until full nutritional goal (25Kcal/Kg)

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
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 * COPD * Preoperative Radiotheraly/chemotherapy * Unresectable primary cancer * Palliative surgery

Design outcomes

Primary

MeasureTime frame
To evaluate the impact of early postoperative enteral feedingPostoperative 21 days

Secondary

MeasureTime frame
To evaluate the nutritional statusPostoperative 6 months

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026