Intravenous Human Albumin In Improving Pancreaticoduodenectomy Outcomes

National University of Malaysia (UKM)

Status and phase: Enrolling; Phase 2

Conditions: Pancreatic Fistula; Delayed Gastric Emptying; Pancreaticoduodenectomy; Anastomotic Leak; Pancreatic Cancer

Treatments: Drug: Human albumin

Study type: Interventional

Funder types: Other

Identifiers

NCT04418739

JEP-2019-796

Details and patient eligibility

About

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.

Full 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.

Enrollment: 122 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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122 participants in 2 patient groups

Control Arm

No Intervention group

Description:

Standard intraoperative fluid regime

Treatment Arm

Experimental group

Description:

Intravenous human albumin 1g/kg at skin incision running at 100ml/hour

Treatment:

Drug: Human albumin