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Limited Routine Total Parenteral Nutrition versus oral diet progression post Whipple procedure to assess affect on patient functionality

Limited Routine Total Parenteral Nutrition versus oral diet progression post pancreaticoduodenectomy procedure to evaluate the role of parenteral nutrition on Patient functionality

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000152123
Enrollment
20
Registered
2019-02-01
Start date
2019-04-29
Completion date
2020-12-21
Last updated
2021-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to investigate the effectiveness of two methods of food introduction following a pancreaticoduodenectomy (otherwise known as Whipple procedure). Who is it for? You may be eligible for this study if you are aged 18 or over, and are undergoing a pancreaticoduodenectomy (or Whipple procedure) at Royal Prince Alfred Hospital in Sydney. Study details Participants will be randomised by chance into two groups. After their planned Whipple procedure, each group will follow a similar nutritional plan, reintroducing foods in a defined manner. One group (the ‘intervention’) will also have nutritional supplementation through a needle in the shoulder placed before surgery. For the 7 days after surgery and one month later, both groups will complete a number of questionnaires and strength tests. It is hoped this research will demonstrate the feasibility of performing the study and, to see if there is an improvement in a participants overall function if they get the food via a needle compared to the usual diet progression after the surgery.

Interventions

All patients will follow the RPA Whipple’s protocol for oral diet progression. Oral diet: NBM day 0-1, Clear Fluid diet day 2-4, Full Fluid diet day 3-5, Post Gastrectomy diet day >4. Where clear diet is clear liquids only, full fluid diet is opaque liquids only and post gastrectomy diet is a diet and meal frequency appropriate for patients in the early post-operative phase after a gastrectomy or oesophagogastrectomy, and to minimise risk of dumping syndrome or oesophageal blockage (as per NSW A

All patients will follow the RPA Whipple’s protocol for oral diet progression. Oral diet: NBM day 0-1, Clear Fluid diet day 2-4, Full Fluid diet day 3-5, Post Gastrectomy diet day >4. Where clear diet is clear liquids only, full fluid diet is opaque liquids only and post gastrectomy diet is a diet and meal frequency appropriate for patients in the early post-operative phase after a gastrectomy or oesophagogastrectomy, and to minimise risk of dumping syndrome or oesophageal blockage (as per NSW Agency of Clinical Innovation diet specifications] . The intervention group (n = 10) patients will be placed on TPN within 24hrs post pancreaticoduodenectomy with oral diet progression. TPN will be calculated to meet patient’s estimated nutritional requirements using Schofield Equation. TPN will be titrated to goal rate using existing practice as per hospital policy “Parental Nutrition (ICU patients)”.TPN will be given via pre-existing central line inserted pre-op. IV fluids given to intervention arm as per RPA Hospital Pancreaticoduodenectomy Checklist [IVT Day 0 post-operatively use Hartman’s Solution. Chart rate at 150mls/hour and on the ward if a fluid bolus is required, the preference is to use 100mls 20% Albumin] Diet progression: Day 0-1: NBM + TPN goal rate Day 2-4: Clear Fluid diet + TPN goal rate Day 3-5: Full Fluid diet + TPN half goal rate Day > 4: Post Gastrectomy diet + TPN half goal rate or ceased In addition to the above as deeded appropriate by the medical team, the patients may receive: IV fluids to meet hydration needs, oral nutritional supplements as appropriate (if oral intake is inadequate to meet estimated nutritional requirements alone). The number of days from initial surgery to when the TPN is ceased will be recorded. Measurement data will be stored via a secure method within REDCap. The pre-operative and intra-operative data is already collected by the Hospital Upper Gastrointestinal Outcomes database (HUGO) (Protocol No X16-0068 & HREC/16/RPAH/84). Baseline: Weight, BMI, Grip strength, QOL questionnaire [EQ-5D-5L] and 24hr food recall. Day 1 post-op: Subjective Global Assessment (SGA) Day 3: Grip strength, weight, BMI, % weight loss, 24hrs dietary recall on total calorie + protein intake and TPN nutritional contributions. Complications. QOL questionnaire [EQ-5D-5L]. Drain/serum Amylase levels. Day 5: Drain/serum Amylase levels Day 7: Grip strength, weight, BMI, % weight loss, 24hrs dietary recall on total calorie + protein intake and TPN nutritional contributions. QOL questionnaire. [EQ-5D-5L]. Day of discharge: postoperative complications and length of stay. One month post-discharge: number of complication free days, SGA and hand grip strength. To be collected in the Gastro Dietetics Outpatient Clinic. QOL questionnaire [EQ-5D-5L] One assessor will be collecting the data; Kiah Witney-Cochrane.

Sponsors

Sydney Local Health District
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

- Patients undergoing intended curative pancreaticoduodenectomy at RPAH, inclusive of other extended surgical procedures. - Ability to provide written consent - Between 18-99 years of age

Exclusion criteria

- Patient unable to consent due to language barriers or cognitive function. - Procedure abandoned due to disease advancement / not clinically indicated upon starting procedure.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026