Pancreatic Cancer{ERAS}NCT07560540
Nutritional Intervention Implication in Enhanced Recovery After Surgery for Whipple Procedure
A study testing Nutrition Intervention in people with Pancreatic Cancer and Ampulla of Vater Adenocarcinoma, run by University of Veterinary and Animal Sciences, Lahore - Pakistan at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Ampulla of Vater Adenocarcinoma, Billiary Track Cancer
- What is being tested?
- Nutrition Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2025to Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Malignancy of;
- Distal common bile duct
- Pancreatic head
- Periampullary
- Duodenal
- Patients scheduled for elective Whipple's procedure (laparoscopic and open)
- Age 18 and above
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Shalamar Hospital
Lahore, 54000
Javeriya Afzal, MPhil Food and Nutrition, 00923244090078, javeriyaafzal23@gmail.com
About this study
Official title: Implication of Nutritional Intervention in Enhanced Recovery After Surgery for Whipple Procedure/Pylorus Preserving Pancreatoduodenectomy
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.
- Being tested
- Nutrition Intervention
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition InterventionOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Other: Nutrition Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Veterinary and Animal Sciences, Lahore - Pakistan
- Sponsor type
- University, hospital or other
- Collaborators
- Shalamar Institute of Health Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560540
- Sponsor's protocol ID
- NutritionERAS-Whipple
- Acronym
- {ERAS}
- Status last verified
- Dec 2025
- First submitted
- 31 Mar 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32161987Martin 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.
PubMed 31257012Bray 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.
PubMed 30207593