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临床试验/NCT02022553
NCT02022553已完成不适用

Complex Treatment of Rectal Cancer

Voronezh N.N. Burdenko State Medical Academy2 个研究点 分布在 2 个国家目标入组 52 人开始时间: 2006年2月1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
52
试验地点
2
主要终点
tumor reduction

研究概览

简要总结

AIM OF RESEARCH. The aim of our research is to improve the results of the combined treatment of patients with locally advanced rectal cancer using endovascular methods and reservoir and plastic surgery.

TASKS OF RESEARCH.

  1. To assess the immediate and long-term results of combined (chemoradiation and surgical) treatment for locally advanced rectal cancer.
  2. To make a comparative evaluation of the results of independent surgical and combined (chemoradiation and surgery) treatment of patients with locally advanced rectal cancer.
  3. To examine functional results of surgical treatment with the formation of "neosphincter" and "neorectum" in patients with colorectal cancer..
  4. To study features of blood supply to the rectum from the pools of the inferior mesenteric and internal iliac arteries, using the method of selective angiography, in connection with the development of endovascular treatment of rectal cancer.
  5. To develop and introduce into clinical practice method of one-stage selective intra-arterial oil chemoembolization of upper, middle and lower rectal arteries in patients with locally advanced rectal cancer, who have a contraindication to preoperative radiotherapy.
  6. To assess the immediate and long-term results of combined (endovascular and surgical) treatment for locally advanced rectal cancer.
  7. To optimize tactics of combined treatment of locally advanced rectal cancer by developing an algorithm of using chemoradiotherapy and endovascular interventions in the preoperative period.

NOVELTY OF RESEARCH.

  1. As a result of research will be designed and implemented a new method of selective intra-arterial chemoembolization in rectal arteries preoperatively in patients with locally advanced rectal cancer.
  2. Substantiated high effectiveness of the proposed technique for the removal of colonic obstruction and, as a consequence perform radical surgical treatment of these patients.
  3. First developed dosage and concentration of chemotherapeutic agent and embolic agent for safe injection when performing selective intra-arterial chemoembolization of rectal arteries.
  4. Developed complex techniques of selective intra-arterial chemoembolization of rectal arteries preoperatively in patients with locally advanced rectal cancer.
  5. Will be made a comparative analysis of the postoperative period and the evaluation of the quality of life of operated patients Obtained data will be presented for use in clinical practice. POSSIBLE APPLICATION AREAS. Results of the research designed for use in the treatment process of departments of Coloproctology, oncology, as well as the educational process of higher and secondary medical institutions.

EXPECTED EFFECTIVENESS.

It is expected that the use of this method of treatment of patients with locally advanced rectal cancer in clinical practice will provide pronounced effect:

  1. Medical and social - improving the quality of care, preservation of social activity of patients, reducing mortality;
  2. Economic - reducing the time of patients' treatment and reducing the number of therapeutic manipulation;
  3. Science and Technology - improving of the training level of medicine workers in the treatment of patients with rectal cancer.

研究设计

研究类型
Interventional
分配方式
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

  • Clinical diagnosis of rectal cancer T3-4N0-2M0
  • complication of bowel obstruction
  • No allergy on contrast agent
  • Previously not operated about rectal cancer
  • Not older than 75 years

排除标准

  • Older 75 years
  • Previously operated about rectal cancer
  • Allergy to contrast agent
  • No bowel obstruction
  • No rectal cancer
  • No locally advanced rectal cancer
  • Clinical diagnosis of rectal cancer Tis-4N0-2M1 (generalized rectal cancer)

结局指标

主要结局

tumor reduction

时间窗: 5-10 days

次要结局

未报告次要终点

研究者

发起方
Voronezh N.N. Burdenko State Medical Academy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Korotkich Nikolay Nikolaevich

M.D.

Voronezh N.N. Burdenko State Medical Academy

研究点 (2)

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