Intravenous Human Albumin In Improving Pancreaticoduodenectomy Outcomes

June 15, 2022 updated by: Universiti Kebangsaan Malaysia Medical Centre
Pancreaticoduodenectomy (PD), more commonly known as Whipple's surgery is the mainstay treatment for pancreatic head and periampullary cancer. Factors contributing to PD outcomes are broadly categorized to disease-related, patient-related and operative factors. Whereas an inexhaustible list of study exists on looking at reducing PD complication rates with respect to the above-mentioned factors, it was only recently that more attention has been given to the impact of perioperative and intraoperative fluid regimes on PD outcomes. This study takes interest in the impact of intraoperative fluid regimes on PD outcomes. The objective of this investigation is to compare the outcomes with the use of intraoperative intravenous human albumin versus standard intraoperative fluid regimes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized controlled trial being conducted at the Universiti Kebangsaan Malaysia Medical Center (UKMMC) with two arms; the control and treatment arms. The treatment arm will receive intravenous human albumin intraoperatively whilst the control arm will receive standard intraoperative fluid regimes. Primary endpoint will be overall complication rates whilst secondary endpoints are length of hospitalization, length of ICU care, duration of gastroparesis, pancreatic fistula rates, surgical site infection rates, duration of surgery and intraoperative bleeding.

Beyond the intraoperative fluid regimes, postoperative care follows the standardised UKMMC Enhanced Recovery After Surgery (ERAS) protocols which saw an improvement in overall outcomes in patients who underwent pancreaticoduodenectomies (PD). Preoperative care will include nutrition optimisation, counselling, antimicrobial prophylaxis, perioperative glycemic control and near-zero fluid balance.

Data collection will include:

i. preoperative data: age, sex, ethnicity, BMI on admission, date of admission, comorbidities and the New York Heart Association (NYHA) functional status classification. Further information will include biochemical markers such as serum albumin albumin, white cell count (WCC), renal functions.

ii. Intraoperative information: duration of surgery, estimated blood loss, pancreatic duct size, pancreatic texture, amount and type of fluid administered, fluid balances and type of anastomoses.

iii. postoperative data: fluid balances and renal function of postoperative day 1 to 3, duration of ICU stay, readmission to ICU, length of hospital stay, duration to standard feeds, grading of pancreatic fistula (where relevant), surgical site infection, duration to removal of urinary catheter, cardiac complications, renal and pulmonary complications, deep vein thrombosis, re-operation, and mortality.

Study Type

Interventional

Enrollment (Anticipated)

122

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia, 56000
        • Recruiting
        • Universiti Kebangsaan Malaysia Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ian Chik
        • Sub-Investigator:
          • Farrah-Hani Imran
        • Sub-Investigator:
          • Azarinah Izaham
        • Sub-Investigator:
          • Zamri Zuhdi
        • Sub-Investigator:
          • Azlanuddin Azman
        • Sub-Investigator:
          • Razman Jarmin
        • Sub-Investigator:
          • Sarah I Liew
        • Sub-Investigator:
          • Fahrol F Jaafar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients undergoing pancreaticoduodenectomy that can consent to the study

Exclusion Criteria:

  • Patients with known allergy to human albumin
  • Patients of American Society of Anaesthesiologist (ASA) physical status class 3 and above.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Arm
Standard intraoperative fluid regime
Experimental: Treatment Arm
Intravenous human albumin 1g/kg at skin incision running at 100ml/hour
Drug: Human albumin
Intravenous human albumin given at a maximum dose of 1g/kg at skin incision which is infused at 100ml/hour

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Complications
Time Frame: Postoperative complications are recorded from date of surgery to date of documented complications including death, assessed from date of surgery to date of discharge or death, whichever came earlier, for up to 12 months.
Complications are defined as any deviation from the normal postoperative course, graded from I to V following the Clavien-Dindo classification of complications whereby Grade I are mild complications not needing any additional interventions and Grade V equates to the most severe complication which is death.
Postoperative complications are recorded from date of surgery to date of documented complications including death, assessed from date of surgery to date of discharge or death, whichever came earlier, for up to 12 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Hospital Stay
Time Frame: From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months
Duration of days of hospitalization
From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months
Length of ICU stay
Time Frame: From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months
Duration of stay in ICU (in days), where relevant
From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months
Postoperative Pancreatic Fistula (POPF) rates
Time Frame: From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months
Rates of postoperative pancreatic fistula
From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months
Delayed Gastric Emptying
Time Frame: From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months
Rates of prolonged gastroparesis
From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months
Ease of surgery
Time Frame: Duration is measured from the start time till the end time of surgery and will be assessed at the end of surgery for up to 12 months
Measured in duration of surgery (in hours & mins)
Duration is measured from the start time till the end time of surgery and will be assessed at the end of surgery for up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Kebangsaan Malaysia Medical Centre

Investigators

  • Study Chair: Ian Chik, Universiti Kebangsaan Malaysia Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2020

Primary Completion (Anticipated)

November 26, 2022

Study Completion (Anticipated)

November 26, 2022

Study Registration Dates

First Submitted

March 25, 2020

First Submitted That Met QC Criteria

June 2, 2020

First Posted (Actual)

June 5, 2020

Study Record Updates

Last Update Posted (Actual)

June 16, 2022

Last Update Submitted That Met QC Criteria

June 15, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JEP-2019-796

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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