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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implication of Nutritional Intervention in Enhanced Recovery After Surgery for Whipple Procedure/Pylorus Preserving Pancreatoduodenectomy
- ClinicalTrials.gov ID
- NCT07560540
- Acronym / sponsor ID
- {ERAS} / NutritionERAS-Whipple
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Veterinary and Animal Sciences, Lahore - PakistanUniversity, hospital or other
- Collaborators
- Shalamar Institute of Health Sciences
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: Nutrition Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Malignancy of;
- Patients scheduled for elective Whipple's procedure (laparoscopic and open)
- Age 18 and above
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition InterventionPersonalized 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) | Other | Treatment |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Background: PubMed 32161987Melloul 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.
- Background: PubMed 31257012Martin 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.
- Background: PubMed 30207593Bray 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Javeriya Afzal, MPhil Food and Nutrition (00923244090078, javeriyaafzal23@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07560540, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.