Lipid bolus for Hepatopancreaticobiliary Cancer

The Ottawa Hospital - General Campus, Ottawa, Canada
Hepatopancreaticobiliary Cancer+2 More ConditionsLipid bolus - DietarySupplement
Eligibility
18+
All Sexes

Study Summary

This trial is testing whether a perioperative immunosupplement can improve immune function following surgery for HPB malignancy.

Eligible Conditions
  • Hepatopancreaticobiliary Cancer
  • Pancreatic Cancer
  • Surgery

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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Study Objectives

1 Primary · 11 Secondary · Reporting Duration: Date of surgery to date of death, assessed upto 3-years after surgery

Date of surgery to date of death, assessed upto 3-years after surgery
Overall Survival
Date of surgery to date of recurrence, assessed up to 3-years after surgery
Disease-free survival
Day of surgery to 30-days after surgery
Secondary immune function outcomes: Immune cell subsets
Secondary immune function outcomes: NK cell activating and inhibitory receptors
Secondary immune function outcomes: amino acid levels
Day of surgery to 90-days after surgery
90-day postoperative complications (Clavien-Dindo 3-5)
90-day postoperative mortality
Incidence of liver insufficiency
Incidence of pancreatic fistula
Communicable Diseases
Day of surgery to day of discharge after surgery, assessed until day of discharge after surgery occurs
Length of stay
Day 1
Natural killer (NK) cell killing

Trial Safety

Phase-Based Safety

1 of 3

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Trial Design

3 Treatment Groups

Group B
1 of 3
Group A
1 of 3
Comparator
1 of 3

Active Control

Experimental Treatment

Non-Treatment Group

45 Total Participants · 3 Treatment Groups

Primary Treatment: Lipid bolus · Has Placebo Group · N/A

Group AExperimental Group · 2 Interventions: Active A, Lipid bolus · Intervention Types: DietarySupplement, DietarySupplement
Group BActiveComparator Group · 2 Interventions: Active A, Placebo oil · Intervention Types: DietarySupplement, DietarySupplement
ComparatorPlaceboComparator Group · 2 Interventions: Active B, Placebo oil · Intervention Types: DietarySupplement, DietarySupplement

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: date of surgery to date of death, assessed upto 3-years after surgery

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
615 Previous Clinical Trials
1,470,521 Total Patients Enrolled
Enhanced Medical NutritionIndustry Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
Sunnybrook Health Sciences Centre Clinical Research Grant CompetitionUNKNOWN
Sunnybrook Health Sciences Centre AFP Innovation FundUNKNOWN

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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References

Frequently Asked Questions

How many individuals are involved in the trial thus far?

"Affirmative. Clinicaltrials.gov shows that the trial, which was initially posted on June 16th 2021 is actively seeking participants. 45 individuals will be enrolled from two medical centres for this investigation." - Anonymous Online Contributor

Unverified Answer

Is there space to enroll in this experiment at the present moment?

"Affirmative. Clinicaltrials.gov hosts details which verify that this medical trial, originally posted on June 16th 2021, is presently recruiting patients from two sites for a total of 45 people." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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