Intravenous Human Albumin In Improving Pancreaticoduodenectomy Outcomes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Intravenous Human Albumin In Improving Pancreaticoduodenectomy Outcomes

Conditions
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Pancreatic Fistula, Pancreatic Cancer, Pancreaticoduodenectomy, Delayed Gastric Emptying, Anastomotic Leak

Intervention / Treatment
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* Drug: Human albumin


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a randomized controlled trial conducted at the University Kebangsaan Malaysia Medical Center (UKMMC) with two arms; a control a treatment arm. The treatment arm will receive intravenous human albumin intraoperatively whilst the control arm will receive standard intraoperative fluid regimes.
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Complications | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreaticoduodenectomy, Postoperative Pancreatic Fistula, Pancreatic Cancer, Intravenous Human Albumin