Preoperative Nutritional Support in Esophagectomy or Pancreaticoduodenectomy

Preoperative Nutritional Support Reduces Postoperative Stay and Incidence of Complications in Patients Undergoing an Esophagectomy or Pancreaticoduodenectomy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00585624

Enrollment

344

Registered

2008-01-03

Start date

2007-04-30

Completion date

2009-10-31

Last updated

2015-10-08

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

Conditions

Esophagectomy, Pancreaticoduodenectomy

Keywords

Esophagectomy, Pancreaticoduodenectomy, Whipple

Brief summary

We are proposing to evaluate the benefit of preoperative nutritional support with Impact Advanced Recovery in the most vulnerable group of elective gastrointestinal surgery patients who may experience a complication, esophagus and pancreas resections, and hypothesize that oral supplementation with 3 servings (0.75 L) Impact Advanced Recovery will reduce postoperative stay by 10-20% and reduce the incidence of major complications by 25%.

Interventions

DIETARY_SUPPLEMENTImpact Advanced Recovery

Nutritional supplement

DIETARY_SUPPLEMENTNo supplement

No supplement

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Male or female age 18 years or older of any race-ethnicity who will undergo an elective esophagectomy or pancreaticoduodenectomy. 2. Surgery will be scheduled 5-7 days after consent date -

Exclusion criteria

1. Surgery is urgent or emergent and/or patient would be unable to consume nutritional supplement for 5-7 days 2. Patient is currently receiving enteral (tube) or parenteral (IV) nutritional support 3. Patients with known pre-existing renal failure requiring a low protein diet 4. Patient is unable to drink 3 servings/day of a liquid supplement -

Design outcomes

Primary

Measure	Time frame
Postoperative stay in days	Postoperative stay in hospital & 30 days

Secondary

Measure	Time frame
Incidence of major complications	Postoperative stay in hospital & 30 days

Countries

United States

Outcome results

None listed

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