Joliat Gaëtan-Romain, Martin David, Labgaa Ismail, Melloul Emmanuel, Uldry Emilie, Halkic Nermin, Fotsing Ginette, Cristaudi Alessandra, Majno-Hurst Pietro, Vrochides Dionisios, Demartines Nicolas, Schäfer Markus
Department of Visceral Surgery, Lausanne University Hospital CHUV, University of Lausanne (UNIL), Lausanne, Switzerland.
Graduate School for Health Sciences, University of Bern, Bern, Switzerland.
Front Oncol. 2022 Jun 28;12:855784. doi: 10.3389/fonc.2022.855784. eCollection 2022.
Malnutrition has been shown to be a risk factor for postoperative complications after pancreatoduodenectomy (PD). In addition, patients needing a PD, such as patients with pancreatic cancer or chronic pancreatitis, often are malnourished. The best route of postoperative nutrition after PD remains unknown. The aim of this randomized controlled trial is to evaluate if early postoperative enteral nutrition can decrease complications after PD compared to oral nutrition.
This multicenter, open-label, randomized controlled trial will include 128 patients undergoing PD with a nutritional risk screening ≥3. Patients will be randomized 1:1 using variable block randomization stratified by center to receive either early enteral nutrition (intervention group) or oral nutrition (control group) after PD. Patients in the intervention group will receive enteral nutrition since the first night of the operation (250 ml/12 h), and enteral nutrition will be increased daily if tolerated until 1000 ml/12 h. The primary outcome will be the Comprehensive Complication Index (CCI) at 90 days after PD.
This study with its multicentric and randomized design will permit to establish if early postoperative enteral nutrition after PD improves postoperative outcomes compared to oral nutrition in malnourished patients.
https://clinicaltrials.gov/(NCT05042882) Registration date: September 2021.
营养不良已被证明是胰十二指肠切除术（PD）术后并发症的一个危险因素。此外，需要进行PD的患者，如胰腺癌或慢性胰腺炎患者，往往存在营养不良。PD术后最佳的营养途径仍不明确。这项随机对照试验的目的是评估与口服营养相比，术后早期肠内营养能否降低PD术后的并发症。
这项多中心、开放标签、随机对照试验将纳入128例营养风险筛查≥3且接受PD的患者。患者将按1:1比例采用中心分层可变区组随机化方法，在PD术后接受早期肠内营养（干预组）或口服营养（对照组）。干预组患者自手术当晚开始接受肠内营养（250毫升/12小时），如果耐受，肠内营养每天增加，直至1000毫升/12小时。主要结局将是PD术后90天的综合并发症指数（CCI）。
这项具有多中心和随机设计的研究将能够确定，与口服营养相比，PD术后早期肠内营养是否能改善营养不良患者的术后结局。
