Anastomotic Leak, Delayed Gastric Emptying, Pancreatic Cancer, Pancreatic Fistula, Pancreaticoduodenectomy
Conditions
Keywords
Pancreaticoduodenectomy, Postoperative Pancreatic Fistula, Pancreatic Cancer, Intravenous Human Albumin
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.
Interventions
DRUGHuman albumin
Intravenous human albumin given at a maximum dose of 1g/kg at skin incision which is infused at 100ml/hour
Sponsors
Universiti Kebangsaan Malaysia Medical Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Complications | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | 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 |
| Length of ICU stay | 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 |
| Postoperative Pancreatic Fistula (POPF) rates | 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 |
| Delayed Gastric Emptying | From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months | Rates of prolonged gastroparesis |
| Ease of surgery | 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) |
Countries
Malaysia
Contacts
Primary ContactIan Chik
Backup ContactSarah I Liew
Outcome results
None listed