Department of Surgery, Zuyderland Medical Centre, Heerlen, The Netherlands
Department of Surgery, Zuyderland Medical Centre, Heerlen, The Netherlands.
BMJ Open. 2023 Jul 4;13(7):e067981. doi: 10.1136/bmjopen-2022-067981.
Oesophageal cancer (EC) and gastric cancer (GC) are among the top 10 cancers worldwide. Both diseases impact the nutritional status of patients and their Quality of Life (QoL). Preoperative malnutrition is reported in 42%-80%. However, studies investigating postoperative nutritional status are limited, and postoperative identification and treatment of micronutrient and macronutrient deficiencies are currently lacking in (inter-)national guidelines. The aim of this study is to identify and target micronutrient deficiencies after surgery for oesophagogastric neoplasms.
This is a single-centre prospective intervention trial performed in Zuyderland Medical Centre. 248 patients who underwent oesophagectomy (n=124) or (sub)total gastrectomy (n=124) from 2011 until 2022 will be included. Both groups will receive Calcium Soft Chew D3 and a multivitamin supplement (MVS) specifically developed according to the type of operation patients underwent; the oesophagectomy group will receive Multi-E and the gastrectomy group will receive Multi-G. The MVSs will be taken once daily and Calcium Soft Chew D3 two times per day. Supplementation will start after baseline measurements. At baseline (T0), blood withdrawal for micronutrient analysis and faecal elastase-1 analysis for exocrine pancreatic insufficiency (EPI) will be performed. Additionally, patients will receive questionnaires regarding QoL and dietary behaviour. After 180 days of supplementation (T1), baseline measurements will be repeated, and the supplement tolerance questionnaire will be completed. Measurements will also be conducted after 360 days (T2) and after 720 days (T3) of supplementation. The main study parameter is micronutrient deficiency (yes/no) for all measurements. Secondary parameters include occurrence of EPI (n, %), diarrhoea (n, %), steatorrhoea (n, %) or bloating (n, %), time between surgery and start of supplementation (mean in months), and QoL at all time points.
The study was approved by the Zuyderland Medical Centre Ethics Committee, Heerlen, the Netherlands. The findings will be disseminated through scientific congresses and in peer-reviewed journals.
NCT05281380.
食管癌（EC）和胃癌（GC）是全球十大癌症之一。这两种疾病都会影响患者的营养状况和生活质量（QoL）。术前营养不良的报告发生率为 42%-80%。然而，目前针对术后营养状况的研究有限，且国际指南中目前缺乏对术后微量营养素和宏量营养素缺乏的识别和治疗。本研究旨在确定并针对胃食管肿瘤手术后的微量营养素缺乏进行治疗。
这是一项在 Zuyderland 医疗中心进行的单中心前瞻性干预试验。将纳入 2011 年至 2022 年期间接受食管切除术（n=124）或（部分）全胃切除术（n=124）的 248 名患者。两组患者均将接受专门根据患者手术类型开发的钙软咀嚼 D3 和多种维生素补充剂（MVS）；食管切除术组将接受 Multi-E，胃切除术组将接受 Multi-G。MVS 将每天服用一次，钙软咀嚼 D3 将每天服用两次。补充剂将在基线测量后开始。在基线（T0）时，将进行微量营养素分析和粪便弹性蛋白酶-1 分析以检测外分泌胰腺功能不全（EPI），并进行血液采集。此外，患者将接受有关生活质量和饮食行为的问卷调查。在补充 180 天后（T1），将重复基线测量，并完成补充剂耐受性问卷。在补充 360 天（T2）和 720 天（T3）后也将进行测量。主要研究参数是所有测量的微量营养素缺乏（是/否）。次要参数包括 EPI 发生情况（n，%）、腹泻（n，%）、脂肪泻（n，%）或腹胀（n，%）、手术与开始补充之间的时间（以月为单位）以及所有时间点的生活质量。
该研究已获得荷兰泽兰医疗中心伦理委员会的批准。研究结果将通过科学会议和同行评议期刊进行传播。
NCT05281380。
