跳至主要内容
临床试验/NCT04438447
NCT04438447Unknown不适用

ERAS Versus ERAS Plus Artificial Nutrition in Open Pancreatoduodenectomy

University of Milano Bicocca2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2022年4月14日最近更新:
适应症

试验速览

阶段
不适用
入组人数
240
试验地点
2
主要终点
Comprehensive Complication Index (CCI)

研究概览

简要总结

there is a need of a randomised clinical trial specifically design to explore whether given a full nutritional requirement by parenteral feeding in the first 5 days after surgery coupled with oral food "at will" compared to only oral food "at will", within an established ERAS program, could achieve a reduction of the morbidity burden

详细描述

Background

The enhanced recovery after surgery (ERAS) protocol is currently considered the gold-standard clinical pathway for perioperative care (1). This protocol is a bundle of interventions derived from the best evidence-based perioperative treatments (1). The aim of the ERAS protocol is to accelerate patient recovery through the reduction of the dysmetabolic consequences of surgical and anesthesiology injury. When the ERAS protocol is implemented, it has been shown a reduction of the rate of surgery-related complication, length of hospital stay, and health care costs (1).

The achievement of single ERAS items also facilitates a faster recovery of oral food intake and of several key metabolic pathways (2). Appropriate tissue healing and recovery/maintenance of organ function after an operation needs an effective and efficient metabolic response, which in turn necessitates adequate qualitative and quantitative nutritional substrates to be effective. Most of the evidence on the advantages of implementing an ERAS program are derived from trials conducted in patients undergoing colorectal surgery. In this cohort the baseline nutritional risk and the rate of malnutrition is less than 10% (3). Moreover, the growing use of minimally invasive techniques has facilitated a faster recovery of bowel function and optimal tolerance of early food resumption after surgery (4). As a result, patients who receive a laparoscopic colorectal resection easily tolerate at once the reintroduction of normal food after the operation and can achieve the full nutritional requirement within 2/3 days (5).

Conversely, major pancreatic resections represent one of the most complex and challenging abdominal operation that do not fit with laparoscopic approach with exception of very selective cases (6). Furthermore, the proportion of patients having a high nutritional risk or are malnourished at baseline is higher than 80% (7). On the top, pancreatic surgery is characterized by peculiar complications such as primary delayed gastric emptying (DGE) or secondary DGE after the occurrence of a pancreatic fistula. These events are frequent (up to 50%) (8) and deeply compromise the regular resumption of oral feeding posing patients at risk of severe underfeeding. Therefore, beside the fact that early oral feeding after pancreatic surgery seems safe, there are no convincing data on whether the goal of attaining adequate nutritional needs is accomplished by a pure ERAS protocols (9) which endorse the use of artificial nutrition only in selected cases (6). However, the level of evidence is low. In fact, only one trial has specifically addressed this issue (10). In this study, the mean daily calorie and protein intakes in the first 2 weeks were similar in the ERAS group and the other group managed conventionally, despite the fact that during the first five post-operative days, the mean daily intakes of calories and proteins slightly favored the ERAS group. Overall, the authors showed that the total energy goals through oral feeding were quite low in both groups.

Many of the published studies did not analyze the compliance with ERAS protocols and reported incomplete data, particularly on early oral feeding (11,12). Robertson et al. (13) reported compliance rates of 82% for resumption of oral fluids and 86% for tolerance of the diet. Conversely, in another large trial (14), postoperative oral liquids were tolerated by 55% of the patients and solid food in 53%, but compliance dropped substantially in patients with major complications.

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

Patients will be randomly allocated to ERAS or ERAS plus PN at 8:00 PM of the first postoperative days. Randomisation will be performed by a computed-generated permuted-block sequence. A specific code will be generated for each centre to achieve equivalent grouping. The allocation ratio will be 1:1 with a block size of 4. Randomization will be competitive among centers.

Surgeons will not be blinded to treatment arm. Masking to allocation will be impossible to achieve for the nature of the study. Patients will be evaluated for outcomes by assessors not directly involved in patient care and masked to patient allocation

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (age ≥ 18 and < 90 years of age) candidate to elective pancreatoduodenectomy for any periampullary or pancreatic cancer

排除标准

  • American Society of Anaesthesiologists (ASA) physical status classification > 3
  • Weight loss > 15% with respect to usual weight in the last 6 months
  • Child-Pugh > A
  • Not signed consent
  • Palliative surgery
  • Placement of a naso-enteric or jejunostomy feeding tube

结局指标

主要结局

Comprehensive Complication Index (CCI)

时间窗: within 30 days after hospital discharge

The primary endpoint of the trial is the complication burden as measured by the Comprehensive Complication Index (CCI)

次要结局

  • Clavien-Dindo severity score(30 days after discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Luca Vittorio Gianotti

Professor of surgery

University of Milano Bicocca

研究点 (2)

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