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NCT Number: NCT07560540

Nutritional Intervention Implication in Enhanced Recovery After Surgery for Whipple Procedure

The objective of this research is to assess the impact of personalized nutritional intervention on postoperative complications and length of stay in Whipple's patients via assessing the parameters related to body composition, nutritional status, weight maintenance, biochemical profile (LFTs, RFTs, CBC, CRP, serum electrolytes, coagulation profile and HbA1c) and muscle preservation postoperatively. Moreover, enhanced recovery after surgery (ERAS) guidelines in Whipple's patients will also be monitored. Exactly 20 patients undergoing Whipple's Procedure/PPPD in 1 year will be recruited for the study. Medical nutrition therapy will include energy intake of 25- 30 Kcal/kg body weight and protein 1.2-1.5g/kg body weight. Enteral nutrition and parenteral nutrition will be given accordingly. After discharge, patients receiving chemotherapy and patients not receiving chemotherapy will be nutritionally intervened accordingly. Follow-ups will be done in the 2nd week, 3rd month and 6th month after surgery. Data will be analyzed using SPSS version 27. To assess the significant difference among study groups t-test, repeated measure analysis of variance (ANOVA) and regression model will be applied. The level of significance will be kept at 5%. t-test for treatment groups.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shalamar Hospital

Lahore, 54000, Pakistan

Location status: Recruiting

Location contact

Javeriya Afzal, MPhil Food and Nutrition

CONTACT

[email protected]

00923244090078

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Malignancy of;
  • Distal common bile duct
  • Pancreatic head
  • Periampullary
  • Duodenal
  • Patients scheduled for elective Whipple's procedure (laparoscopic and open)
  • Age 18 and above

Exclusion criteria

  • Patients undergoing Whipple's procedure for reasons other than malignancy
  • Patients undergoing emergency procedures
  • Patients with significant preoperative complications prohibiting oral intake
  • Age below 18

Treatment and study plan

Nutrition Intervention

Other

Personalized Nutrition Intervention (Medical nutrition therapy will include energy intake of 25- 30 Kcal/kg body weight and protein 1.2-1.5g/kg body weight using enteral nutrition)

Primary outcomes

  1. Evidence-based data for ERAS focusing on nutritional recommendations in Whipple's Procedure/PPPD will be generated for the Pakistani population.

    Time frame: 2 years

    The research and evidence-based data for ERAS focusing on nutritional recommendations in Whipple's Procedure/PPPD will be generated for the Pakistani population.

    The impact of the nutritional intervention with the available resources will be measured by Body Composition Analysis, Patient Generated Subjective Global Assessment and Biochemical Profiling.

Study contacts

Contact information is provided by the study sponsor or research team.

Javeriya Afzal, MPhil Food and Nutrition

CONTACT

[email protected]

00923244090078

Sponsors and collaborators

Lead sponsor

University of Veterinary and Animal Sciences, Lahore - Pakistan

Other

Collaborators

  • Shalamar Institute of Health Sciences

Registry information

Official study title

Implication of Nutritional Intervention in Enhanced Recovery After Surgery for Whipple Procedure/Pylorus Preserving Pancreatoduodenectomy

Acronym: {ERAS}

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 1, 2026
Registry last updated
May 1, 2026

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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