Intravenous Human Albumin In Improving Pancreaticoduodenectomy Outcomes
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Overall Complications
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients undergoing pancreaticoduodenectomy that can consent to the study
排除标准
- •Patients with known allergy to human albumin
- •Patients of American Society of Anaesthesiologist (ASA) physical status class 3 and above.
研究组 & 干预措施
Treatment Arm
Intravenous human albumin 1g/kg at skin incision running at 100ml/hour
干预措施: Human albumin (Drug)
结局指标
主要结局
Overall Complications
时间窗: 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.
次要结局
- Length of Hospital Stay(From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months)
- Length of ICU stay(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(From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months)
- Delayed Gastric Emptying(From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months)
- 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)