Intravenous Human Albumin In Improving Pancreaticoduodenectomy Outcomes

Phase 2

• Conditions: Pancreaticoduodenectomy; Pancreatic Cancer; Anastomotic Leak; Pancreatic Fistula; Delayed Gastric Emptying
• Interventions: Drug: Human albumin

• Registration Number: NCT04418739
• Lead Sponsor: Universiti Kebangsaan Malaysia Medical Centre

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.

Study Timeline

• Study Start: 2020-01-27
• Study First Submitted: 2020-03-25
• Study First Submitted QC: 2020-06-02
• Study First Posted: 2020-06-05
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-15
• Last Update Posted: 2022-06-16
• Primary Completion: 2022-11-26
• Study Completion: 2022-11-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 122

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Arm	Human albumin	Intravenous human albumin 1g/kg at skin incision running at 100ml/hour

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Universiti Kebangsaan Malaysia Medical Center; 🇲🇾 Kuala Lumpur, Malaysia