Clinical trial NCT04418739: Intravenous Human Albumin In Improving Pancreaticoduodenectomy Outcomes
Official title: Intravenous Human Albumin In Improving Pancreaticoduodenectomy Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pancreaticoduodenectomy
Pancreatic Fistula
Delayed Gastric Emptying
Pancreatic Cancer
Anastomotic Leak
Keywords: Pancreaticoduodenectomy
Postoperative Pancreatic Fistula
Pancreatic Cancer
Intravenous Human Albumin
Lead sponsor: Universiti Kebangsaan Malaysia Medical Centre
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 122
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall Complications
timeFrame: 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 outcomes:
measure: Length of Hospital Stay
timeFrame: From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months
measure: Length of ICU stay
timeFrame: From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months
measure: Postoperative Pancreatic Fistula (POPF) rates
timeFrame: From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months
measure: Delayed Gastric Emptying
timeFrame: From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months
measure: Ease of surgery
timeFrame: 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
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Universiti Kebangsaan Malaysia Medical Center
Study officials:
affiliation: Universiti Kebangsaan Malaysia Medical Center
name: Ian Chik
role: STUDY_CHAIR
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