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Completed

NCT Number: NCT01789073

Preoperative Oral Immunonutrition for Patients With Pancreatic Cancer Undergoing Elective Surgery - Effect on Complications and Length of Hospital Stay

The purpose of this study is to investigate the effect of preoperative immunonutrition on complications and length of hospital stay in patients with pancreatic cancer undergoing elective surgery.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Surgical Gastroenterology Clinic C, Ward 2122, Rigshospitalet

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women referred to treatment at Surgical Gastroenterology Clinic C, Ward 2122 for pancreatic cancer
  • Age > 18 years.

Exclusion criteria

  • Age < 18 years
  • Pregnant and lactating women
  • Persons who cannot understand and/or speak Danish
  • Renal dysfunction
  • Milk allergy
  • Participants are excluded if elective surgery is not indicated after all

Treatment and study plan

Oral Impact, Nestlé Health Science

Dietary Supplement

Oral Impact from Nestlé Health Science. An enteral nutritional supplement high in protein and with added immune-enhancing nutrients: arginine, fish oil and nucleotides. The intervention arm receives Oral Impact in an individually estimated dosage according to a protein requirement of 1.5 g/kg bodyweight/day (subtracted their habitual protein intake). Each patient receives this dosage orally the last 7 days prior to surgery.

Primary outcomes

  1. Overall postoperative complications after major gastrointestinal (GI) elective surgery.

    Time frame: Within the first 30 days after surgery

Secondary outcomes

  1. Length of hospital stay after major gastrointestinal (GI) elective surgery

    Time frame: Within the first 30 days after surgery

Other outcomes

  1. Weight stability, functional capability and patients´ satisfaction with the overall study course.

    Time frame: from recruitment and within 30 days after surgery

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Rigshospitalet, Denmark

Registry information

Official study title

Randomized, Controlled Trial Investigating the Effect of Preoperative Oral Immunonutrition on Complications and Length of Hospital Stay After Elective Surgery for Pancreatic Cancer

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 11, 2013
Registry last updated
Dec 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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