The Effect of Enhanced Recovery After Surgery (ERAS) on Pancreaticoduodenectomy in Patients With Hepatobiliary-Pancreas (HBP) Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 334
- 试验地点
- 2
- 主要终点
- Functional recovery date on postopreative 7th day
研究概览
简要总结
Enhanced Recovery After Surgery (ERAS) is not a program that aims to reduce postoperative hospital stay, but the multimodal strategies that aim to attenuate the loss of, and improve the restoration of, functional capacity after surgery on evidence-based medicine. The benefits of ERAS are proven in many surgical procedures, such as upper gastrointestinal surgery and colorectal surgery.
Investigators performed Randomized Controlled Trials to evaluate the non-inferiority of modified ERAS protocol for pancreaticoduodenectomy (PD) by introducing standardized pre- and post-operative treatment based on ERAS treatment guidelines (ERAS on PD, Research Institute Clinical Progress, 2014-0961; ClinicalTrials.gov, NCT02372331). As a result of the study, the ERAS protocol proved to be non-inferior to the existing pre- and post-operative treatment in terms of surgical complications, mortality, hospital stay, total hospital cost, and most nutritional indicators.
However, the previous study did not include a few important intraoperative items such as epidural analgesia and fluid balance among the main items of the ERAS protocol. This trial aims to evaluate the clinical results by applying the complete ERAS protocol.
详细描述
This study was a single-institution, randomized controlled clinical trial to test the superiority of Enhanced Recovery After Surgery (ERAS) protocol for patients with pancreaticoduodenectomy (PD).
This study will be conducted on adult patients who are planning to undergo pancreaticoduodenectomy for the treatment of periampullary disease for 12 months after the start of the study.
Based on the results of the previous study which choose the functional recovery date as a primary outcome (control group; 9.0 ± 4.3 days, intervention group; 7.6 ± 4.3 days), a total of 334 patients (167 patients in each group) will be enrolled when calculated with power 0.8, α = 0.05, a two-tailed test, and a 10% withdrawal rate.
Investigators plan to randomize patients covered by the existing ERAS program to the control group and patients covered by the full ERAS protocol to the experimental group.
Investigators plan to observe the clinical outcomes up to 3 months after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The evaluation and judgment for morbidity (primary endpoint) / mortality (secondary endpoint) was made by Morbidity and Mortality Committee in our division. Committee members were blinded about knowledge of the interventions assigned to individual participants.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 to 80 years old
- •Performance: Eastern Cooperative Oncology Group (ECOG) 0-2
- •Resectable or borderline resectable malignant tumor or borderline malignant tumor on the periampullary area
- •No distant metastases
- •Bone marrow function: White Blood Cell (WBC) at least 3,000/mm3 or Absolute Neutrophil Count (ANC) ≥ 1,500/mm3, Platelet count at least 125,000/mm3
- •Liver function: aspartate aminotransferase (AST) / alanine aminotransferase (ALT) less than 3 times the upper limit of normal
- •Renal function: Creatinine no greater than 1.5 times the upper limit of normal
- •Patients who consented and signed informed consent
排除标准
- •Patients with distant metastases or patients with recurrent periampullary carcinoma
- •Patients with active or uncontrolled infection
- •Patients with severe psychiatric/neurological disorders
- •People who are addicted to alcohol or other drugs
- •Patients included in other clinical studies that may affect this study
- •Patients unable to follow the researcher's instructions
- •Pregnancy
- •Patients with uncontrolled heart disease
- •Patients with moderate or more comorbidities that are judged to have an impact on quality of life or nutritional status (liver cirrhosis, chronic renal failure, heart failure, etc.)
- •Patients who underwent major abdominal organ surgery other than scheduled pancreaticoduodenectomy.
- •Patients who require combined resection of other major abdominal organs in addition to scheduled pancreaticoduodenectomy
- •History of allergy to local anesthetics
- •Local infection at the treatment site
- •Patients with neurological or mental health conditions
- •A history of spinal surgery or compression fractures at abdominal level
- •Patients with coagulopathy (Platelet < 125,000/mm3 or International Normalized Ratio (INR) ≥ 1.5) or who continue to take anticoagulants or antithrombotic drugs without stopping
- •Others who are not suitable for research in the judgment of the clinician
结局指标
主要结局
Functional recovery date on postopreative 7th day
时间窗: The investigators evaluate the five items to the participant starting on the 7th day after surgery. A date that satisfies all five items is defined as functional recovery date.
* Pain control is possible only with oral or patch-type analgesics without intravenous analgesic administration * Able to walk freely * Free eating is possible * There should be no evidence of infection related to surgery * No intravenous nutritional injection (total parenteral nutrition) being administered
次要结局
- Postoperative mortality(90 days after surgery)
- Postoperative complication(Three months after surgery)
- Re-admission rate(3 months after surgery)
研究者
Dae Wook Hwang
Associate professor
Asan Medical Center