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临床试验/NCT02676791
NCT02676791已完成不适用

Influence of Esophageal Washout on Local Carcinoma Recurrence After Curative Resection - a Randomized Controlled Trial

Technische Universität Dresden1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年2月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Local carcinoma recurrence

研究概览

简要总结

The LOCARE-Trial is an investigator initiated, randomized-controlled trial with two parallel arms (n=60 each) and investigates the influence of esophageal washout on long-term outcomes in patients undergoing elective esophageal resection for carcinoma. The primary endpoint is defined as local carcinoma recurrence. Secondary endpoints will be locoregional and distant recurrence, disease-specific survival and esophageal cancer specific survival.

详细描述

Treatment of squamous cell carcinoma and adenocarcinoma of the esophagus has changed rapidly over the last decades due to implementation of multimodal cancer therapies such as radiotherapy or combined radiochemotherapy. Surgery, however, still is the mainstay of curative treatment options for this cancer entity. Due to the significant improvement in surgical technique and perioperative management, the postoperative mortality rate has fallen to about 5% with an estimated 5-year survival of 35%. Nevertheless, patients after esophagectomy are at high risk for local recurrence especially within the first 2 years after treatment. Independent risk factors for the development of carcinoma recurrence are incomplete resection (R1), extracapsular lymph node involvement and postoperative complications. Exfoliated, malignant cells remaining in luminal organs like the esophagus or colorectum could present another important risk factor for local recurrence especially at the site of anastomosis. In the treatment of rectal cancer, data have shown, that intraoperative rectal washout significantly reduces the risk of local recurrence from about 10% to 5%. For this reason, rectal washout during anterior resection has become a standard in many surgical institutions. Besides agents like cetrimide, sodium hypochlorite, formalin or saline, povidone-iodine has also been used for rectal mucosal application in prospective studies. Questions arise, weather similar positive outcomes could be achieved in esophageal surgery. The investigators hypothesize that esophageal washout with a povidone-iodine solution (Betaisodona®, Mundipharma) reduces the risk of local carcinoma recurrence after radical resection.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

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

入选标准

  • Patients scheduled for elective esophageal resection or esophagectomy
  • Age equal or greater than 18 years
  • Written informed consent
  • Squamous cell carcinoma of the esophagus (SCC)
  • Adenocarcinoma of the gastroesophageal junction (AEG) Type I

排除标准

  • Local irresectability or metastatic disease
  • Adenocarcinoma of the gastroesophageal junction Type II and III
  • Histopathological R1-resection
  • Surgery for recurrence
  • Iodine allergy
  • Hyperthyreosis

研究组 & 干预措施

A (Povidone-Iodine)

Experimental

Esophageal washout will be performed via a nasogastric tube with approx. 50ml of a 11% povidone-iodine solution (Betaisodona®, Mundipharma) during esophageal resection.

干预措施: Povidone-Iodine (Drug)

结局指标

主要结局

Local carcinoma recurrence

时间窗: 36 months

Defined as development of a local recurrence after surgical treatment for esophageal cancer. The tumor is of identical histopathological type and occurs either on remained parts of the esophagus, at the site of anastomosis, on parts of an interposed organ (i.e. jejunum or colon) or in the original esophageal bed.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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