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临床试验/NCT05965466
NCT05965466已完成不适用

Effect of Gastric Cancer Surgical Resection Extent on Postoperative Gallstone Formation: A Retrospected Cohort Study

Hepatopancreatobiliary Surgery Institute of Gansu Province2 个研究点 分布在 1 个国家目标入组 531 人开始时间: 2023年7月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
531
试验地点
2
主要终点
Number of gallstone patients

研究概览

简要总结

To provide preventive and therapeutic strategies for participants with gallstones after gastric cancer by comparing the risk of postoperative gallbladder stone formation with two different resection ranges using the Roux-en-Y reconstruction modality in radical gastric cancer surgery.

详细描述

A large number of clinical studies have found that the incidence of gallstones in patients after radical gastric cancer surgery is higher than that in the normal population. However, the pathogenesis has not been clarified, and the prophylactic removal of the gallbladder in patients with gastric cancer remains controversial. A previous study found a statistically significant incidence of gallbladder stones after Billroth I versus Roux-en-Y in distal gastrectomy for gastric cancer. Therefore, the investigators plan to conduct a retrospected cohort study to collect further participants with gastric cancer who underwent total gastrectomy to answer whether different surgical resection ranges during surgery increase the incidence of gallstones this question.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with Gastric Cancer underwent Gastrectomy

排除标准

  • Age less than 18 years or age greater than 75 years;
  • Not Roux-en-Y reconstruction;
  • R0 excision is not achieved;
  • Previous history of upper abdominal surgery, such as cholecystectomy, gastrectomy;
  • Preoperative gallbladder diseases, such as gallstones, gallbladder polyps, chronic cholecystitis;
  • Preoperative neoadjuvant chemotherapy or radiotherapy;
  • Previous history of malignant tumours;
  • Patients with mental or developmental abnormalities or women during pregnancy or breastfeeding;
  • Gastric perforation or bleeding leading to emergency surgery;
  • Palliative surgical treatment;
  • Incomplete case information.

结局指标

主要结局

Number of gallstone patients

时间窗: 5years

Two groups of patients with gastric cancer had a follow-up for more than one year and the number of patients with gallbladder stones on B-ultrasound or Computed Tomography (CT)

次要结局

  • Number of patients with bile duct stones(5years)
  • Number of patients with postoperative complications(5years)

研究者

发起方
Hepatopancreatobiliary Surgery Institute of Gansu Province
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wenbo Meng

Director of Surgery

Hepatopancreatobiliary Surgery Institute of Gansu Province

研究点 (2)

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