跳至主要内容
临床试验/NCT04919577
NCT04919577已完成不适用

Predictive Factors for Roux Stasis Syndrome After Distal Gastrectomy With Roux-en-Y Reconstruction in Gastric Cancer Patients: A Retrospective Comparative Cohort

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2014年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
220
试验地点
1
主要终点
Roux stasis syndrome

研究概览

简要总结

Patients who were pathologically diagnosed with gastric cancer and underwent distal gastrectomy with R-Y reconstruction between March 2014 and March 2021 were retrospectively analyzed. The occurrence of RSS was evaluated and examined for correlations with demographic and clinicopathological data. "R" package was used to build a nomogram.

详细描述

Patient Selection Ethical approval for this study was obtained from the medical ethics research committee of Peking University Third Hospital (IRB00006761-2019173).

Consecutive patients who were pathologically diagnosed with gastric cancer and underwent distal gastrectomy with R-Y reconstruction between March 2014 and March 2021 at Peking University Third Hospital were retrospectively selected (the detailed screening process was shown in Figure 1).

The exclusion criteria for this study were: (1) patients with distant metastasis, (2) patients with palliative surgery, (3) death occurred within 14 days after operation, (4) patients with primary malignant disease in other organs besides stomach.

Surgical Procedure RY reconstruction was performed after standard distal gastrectomy and D2 lymph node dissection. There are several key steps involved in the RY reconstruction process. Firstly, the jejunum was dissected at 20.2cm (average value) distal to Treitz's ligament. Secondly, a side-to-side antecolic gastrojejunostomy was created using a linear stapler between the gastric stump and the distal segment of jejunum. Finally, an end-to-side or side-to-side jejunostomy was performed in output limb at about 37.2cm (average value) distal to the gastrojejunostomy (Figure 2). A cholecystectomy was performed if the patient had gallbladder-related disease.

Data collection We divided these patients into two group depending on whether RSS occurred and retrospectively analyzed the following items: gender, age, body mass index (BMI), smoking, diabetes, high carcinoembryonic antigen (CEA), hypoproteinemia, hyperlipidemia, operation approach, operation time, cholecystectomy, length of input and output loops, intestinal anastomosis approach, pathological T (pT) stage, lymph node metastasis, pathological stage, lymphovascular invasion, nerve invasion and postoperative hospital stay. According to the standard classification of BMI in China11, we divided patients into three groups, including underweight group (BMI < 18.5 kg/m2), obesity group (BMI ≥ 28.0 kg/m2) and normal group (18.5 kg/m2 ≥ BMI < 28.0 kg/m2). The cancer stage was defined according to the 8th cancer Edition Cancer Staging System presented by American Joint Committee on Cancer.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • pathologically diagnosed with gastric cancer
  • underwent distal gastrectomy with R-Y reconstruction
  • the date of admission is between March 2014 and March 2021
  • the admission place is Peking University Third Hospital.

排除标准

  • patients with distant metastasis
  • patients with palliative surgery
  • death occurred within 14 days after operation
  • patients with primary malignant disease in other organs besides stomach.

结局指标

主要结局

Roux stasis syndrome

时间窗: 2014.03.01 to 2021.03.01

Yes or No. We defined RSS as (1) the presence of symptoms such as nausea, vomiting, or abdominal fullness, (2) refasting after liquid or semi-liquid diets, (3) imaging methods (X-ray, CT, upper gastroenterography) confirmed without mechanical obstruction. If all three conditions meet at the same time and occur within 30 days after operation, we choose Yes, otherwise, we choose No.

次要结局

  • Gender(2014.03.01 to 2021.03.01)
  • smoking, diabetes(2014.03.01 to 2021.03.01)
  • Age(2014.03.01 to 2021.03.01)
  • operation approach(2014.03.01 to 2021.03.01)
  • operation time(2014.03.01 to 2021.03.01)
  • cholecystectomy(2014.03.01 to 2021.03.01)
  • postoperative hospital stay(2014.03.01 to 2021.03.01)
  • length of input and output loops(2014.03.01 to 2021.03.01)
  • intestinal anastomosis approach(2014.03.01 to 2021.03.01)
  • lymph node metastasis, lymphovascular invasion, nerve invasion.(2014.03.01 to 2021.03.01)
  • body mass index (BMI)(2014.03.01 to 2021.03.01)
  • high carcinoembryonic antigen (CEA)(2014.03.01 to 2021.03.01)
  • hypoproteinemia(2014.03.01 to 2021.03.01)
  • pathological T (pT) stage(2014.03.01 to 2021.03.01)

研究者

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

Wei Fu

Principal

Peking University Third Hospital

研究点 (1)

Loading locations...

相似试验