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腹腔镜未离断Roux-en-Y术式用于远端胃癌根治术:一项多中心随机对照试验的研究方案

Laparoscopic uncut Roux-en-Y for radical distal gastrectomy: the study protocol for a multirandomized controlled trial.

作者信息

Wang Quan, Ni Qingrong, Yang Kelu, Ji Sheqing, Fan Yong, Wang Chen, Zhang Wenbin, Yan Su, Ma Qi, Wei Qiuya, Zhang Di, Yu Juan, Ji Gang

机构信息

Department of Digestive Surgery, Xijing Hospital of Digestive Disease, Xijing Hospital, The Fourth Military Medical University, Xi'an 710032, China,

Department of General Surgery, Henan Cancer Hospital& Zhengzhou University Cancer Hospital, Zhengzhou University, Zhengzhou 450003, China.

出版信息

Cancer Manag Res. 2019 Feb 19;11:1697-1704. doi: 10.2147/CMAR.S170355. eCollection 2019.

Abstract

Gastric cancer is the third most common cause of cancer-related deaths and is the fifth highest incidence of cancer worldwide, especially in Eastern Asia, Central and Eastern Europe, and South America. Currently, surgery is the only curative treatment for gastric cancer; however, digestive tract reconstruction after distal gastrectomy for gastric cancer is controversial due to the postoperative complications such as reflux gastritis. There is an increasing trend toward laparoscopic uncut Roux-en-Y (URY) for radical gastrectomy. However, evidence on the feasibility of this procedure in patients undergoing laparoscopic radical distal gastrectomy is still absent. Thus, a prospective randomized trial is warranted. This is a prospective, multicenter, two-arm randomized controlled trial in which 210 patients will be randomly assigned to two groups: laparoscopic URY (n=105) and laparoscopic Billroth II plus Braun anastomosis (n=105). Each participant must be pathologically diagnosed with gastric cancer and undergo laparoscopic radical gastrectomy at Xijing Hospital and other four hospitals. The laparoscopic URY procedure is based on the Billroth II gastrojejunostomy plus Braun anastomosis, and then blocked the jejunum input loop at the stump-jejunal anastomosis. The patients' demographic and pathological characteristics will be recorded. The total and oral nutritional intake, general data, total serum protein, serum albumin, blood glucose, and temperature will be recorded before surgery and at the time of hospitalization. Postoperative adverse events will also be recorded, as well as at follow-up appointments at three months and six months after surgery. The rate of reflux gastritis will represent the primary endpoint, and other secondary endpoints, which are all recorded.

摘要

胃癌是癌症相关死亡的第三大常见原因,在全球癌症发病率中排名第五,尤其在东亚、中东欧和南美洲。目前,手术是胃癌唯一的治愈性治疗方法;然而,由于诸如反流性胃炎等术后并发症,胃癌远端胃切除术后的消化道重建存在争议。腹腔镜非离断式Roux-en-Y(URY)根治性胃切除术的趋势正在增加。然而,关于该手术在接受腹腔镜根治性远端胃切除术患者中的可行性的证据仍然缺乏。因此,有必要进行一项前瞻性随机试验。这是一项前瞻性、多中心、双臂随机对照试验,其中210名患者将被随机分为两组:腹腔镜URY组(n = 105)和腹腔镜毕罗Ⅱ式加布朗吻合术组(n = 105)。每位参与者必须经病理诊断为胃癌,并在西京医院和其他四家医院接受腹腔镜根治性胃切除术。腹腔镜URY手术基于毕罗Ⅱ式胃空肠吻合术加布朗吻合术,然后在残端空肠吻合处阻断空肠输入袢。将记录患者的人口统计学和病理特征。在手术前和住院时将记录总营养摄入量和口服营养摄入量、一般数据、总血清蛋白、血清白蛋白、血糖和体温。还将记录术后不良事件,以及术后三个月和六个月随访时的情况。反流性胃炎的发生率将作为主要终点,其他次要终点也都将记录。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b394/6389003/90208f26b650/cmar-11-1697Fig1.jpg

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