Nutritional Intervention Implication in Enhanced Recovery After Surgery for Whipple Procedure

NCT07560540 | Recruiting

• 1 other identifier: NutritionERAS-Whipple
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer; Billiary Track Cancer; Ampulla of Vater Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

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

  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.

  2 years

Study Arms (1)

Treatment

EXPERIMENTAL

Other: Nutrition Intervention

Interventions

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)

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Veterinary and Animal Sciences, Lahore - Pakistan: lead
• Shalamar Institute of Health Sciences: collaborator

Study Sites (1)

Shalamar Hospital

Lahore, 54000, Pakistan

RECRUITING

Related Publications (3)

• Melloul E, Lassen K, Roulin D, Grass F, Perinel J, Adham M, Wellge EB, Kunzler F, Besselink MG, Asbun H, Scott MJ, Dejong CHC, Vrochides D, Aloia T, Izbicki JR, Demartines N. Guidelines for Perioperative Care for Pancreatoduodenectomy: Enhanced Recovery After Surgery (ERAS) Recommendations 2019. World J Surg. 2020 Jul;44(7):2056-2084. doi: 10.1007/s00268-020-05462-w.

  PMID: 32161987 BACKGROUND

• Martin D, Joliat GR, Halkic N, Demartines N, Schafer M. Perioperative nutritional management of patients undergoing pancreatoduodenectomy: an international survey among surgeons. HPB (Oxford). 2020 Jan;22(1):75-82. doi: 10.1016/j.hpb.2019.05.009. Epub 2019 Jun 27.

  PMID: 31257012 BACKGROUND

• Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

  PMID: 30207593 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Central Study Contacts

Javeriya Afzal, MPhil Food and Nutrition

CONTACT

00923244090078; javeriyaafzal23@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: May 1, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)