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2020-01-27
2022-11-26
2022-11-26
122
NCT04418739
Universiti Kebangsaan Malaysia Medical Centre
Universiti Kebangsaan Malaysia Medical Centre
INTERVENTIONAL
Intravenous Human Albumin In Improving Pancreaticoduodenectomy Outcomes
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2020-03-25 | N/A | 2022-06-15 |
2020-06-02 | N/A | 2022-06-16 |
2020-06-05 | N/A | 2022-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Prevention
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| NO_INTERVENTION: Control Arm Standard intraoperative fluid regime | |
| EXPERIMENTAL: Treatment Arm Intravenous human albumin 1g/kg at skin incision running at 100ml/hour | DRUG: Human albumin
|
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Ian Chik Phone Number: +60123243404 Email: ianchikmd@gmail.com |
Study Contact Backup Name: Sarah I Liew Phone Number: +601112218229 Email: liew4689@gmail.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
