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Early Oral Versus Enteral Nutrition After Pancreatoduodenectomy for Periampullary Tumors: a Prospective, Randomized, Controlled Clinical Trial

Phase 4
18 Years
Open (Enrolling)
Pancreatic Cancer, Cancer of the Duodenum, Cholangiocarcinoma, Chronic Pancreatitis

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Trial Information

Early Oral Versus Enteral Nutrition After Pancreatoduodenectomy for Periampullary Tumors: a Prospective, Randomized, Controlled Clinical Trial

Background & aim: Pancreatoduodenectomy carries high morbidity rates even in high-volume
centers. Postoperative complications often preclude or delay adequate oral nutrition and
nutritional support may be required. However, the role of perioperative nutritional
supplementation in well-nourished patients remains controversial. There are not any standard
protocols for nutritional support after major upper gastrointestinal surgery in these
patients and postoperative nutritional regimens depend mainly upon surgeon's or center

Patients undergoing pancreatoduodenectomy often begin oral intake a week after operation and
enteral or parenteral nutrition is used to cover the daily caloric requirements during this
period, although their role still remains questionable. The safety of early oral nutrition
has been confirmed in the majority of gastrointestinal procedures. However, pancreatic
surgeons are quite reluctant to advance oral diet within the first postoperative week after
pancreatoduodenectomy due to fear of anastomosis breakdown or delayed gastric emptying
syndrome. These two postoperative nutritional regimens, early oral vs. early enteral
nutrition, have not been sufficiently evaluated in a prospective, randomized study.

Material and Methods: 96 patients undergoing pancreatoduodenectomy will be randomized to
receive early enteral nutrition (EN group) or early oral nutrition (PerOs group). The EN
group will receive standard enteral diet administered through a nasojejunal tube. The
enteral nutrition will be started on the 1st postoperative day and increased daily by 20-40
ml up to the estimated level. The PerOs group will receive oral diets beginning from the 2nd
postoperative day and oral intake will be advanced as tolerated.

Purpose: The purpose of this study is to compare the influence of early enteral and oral
nutrition on postoperative course and complications after pancreatoduodenectomy.

Inclusion Criteria:

- Primary periampullary tumor

- R0, R1 resection

- Chronic pancreatitis requiring pancreatoduodenectomy

Exclusion Criteria:

- Metastatic tumor

- Locally unresectable tumor

- Previous gastric resection


- Age under 18 years

- Preoperative complete parenteral or enteral feeding

- Immunosuppressive therapy before operation

- Severe malnutrition

- Lack of the patient's consent for the trial participation, feeding tube insertion or
epidural analgesia

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Frequency of delayed gastric emptying

Outcome Time Frame:

30 days after operation

Safety Issue:


Principal Investigator

Maciej SÅ‚odkowski, MD

Investigator Role:

Study Director

Investigator Affiliation:

Medical University of Warsaw


Poland: Ethics Committee

Study ID:




Start Date:

July 2012

Completion Date:

December 2016

Related Keywords:

  • Pancreatic Cancer
  • Cancer of the Duodenum
  • Cholangiocarcinoma
  • Chronic Pancreatitis
  • Periampullary tumor
  • Chronic pancreatitis
  • Pancreatoduodenectomy
  • Oral Nutrition
  • Enteral Nutrition
  • Duodenal Neoplasms
  • Pancreatic Neoplasms
  • Pancreatitis
  • Pancreatitis, Chronic
  • Cholangiocarcinoma