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临床试验/NCT02526836
NCT02526836Unknown2 期

Complete Mesocolic Excision (CME) With Central Supplying Vessel Ligation (CVL) Compared With Conventional Surgery for Colon Cancer: a Double-blinded Randomized Study

Mansoura University4 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2014年9月最近更新:
适应症
干预措施

试验速览

阶段
2 期
入组人数
40
试验地点
4
主要终点
Lymph nodes harvest

研究概览

简要总结

The aim of this study is to compare between complete mesocolic excision with central vascular ligation and conventional surgery of colon cancer regarding number of harvested lymph nodes, surgical outcome and complications.

详细描述

Colorectal cancer is the third most common human malignant epithelial tumor and still represents the second cause of cancer death in the United States and Europe.

Over the past few decades, there have been significant improvements in the treatment of patients with colonic and rectal cancers. In rectal cancer, the role of earlier diagnosis, improved preoperative staging, neoadjuvant therapy and total mesorectal excision have improved outcomes from oncological and patient recovery perspectives. Of these, arguably the most important for the surgeon was the advent of Total Mesorectal Excision (TME).

Current thinking is that colonic tumors spread via hematogenous, lymphatic, and possibly perineural routes, with the lymphatics anatomically following the arterial supply. Current practice is to excise a proportion of the draining lymphatic bed to accurately stage the cancer and also clear possible lymphatic metastases.

Recently, significant debate has centered on the degree of lymphatic clearance required; several reports have demonstrated improved oncologic outcomes with wider lymphovascular resections compared with current standard practice. Whether these improved outcomes are secondary to improved lymph node yield or an alternative technical effect has not yet been ascertained.

In analogy to total mesorectal excision (TME) for rectal cancer complete mesocolic excision was recently introduced for curative treatment of colon cancer. Like TME, CME aims at complete en bloc clearance of the lymphatic drainage of the tumor enveloped in intact fascias of embryologic origin.

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
Double (Participant, Outcomes Assessor)

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

  • Pathologically proven adenocarcinoma (including mucinous and signet-ring cell) or adenosquamous carcinoma on endoscopic biopsy.
  • Tumor localization at the caecum, ascending colon, transverse colon, descending colon, sigmoid colon or rectosigmoid on preoperative endoscopy and radiographic imaging [barium enema or computed tomography (CT)] without location of the lower border of the tumor at the rectum.
  • No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.
  • Body mass index ≤
  • Sufficient organ function including cardiovascular system and liver.
  • Written informed consent.

排除标准

  • Contraindications to major surgery and American Society of Anesthesiologists (ASA) Physical Status scoring 4 which means extreme systemic disorders which have already become an eminent threat to life regardless of the type of treatment.
  • Infectious disease requiring treatment.
  • Body temperature ≥ 38 °C.
  • Pregnant women.
  • History of psychiatric disease.
  • Use of systemic steroids.
  • History of myocardial infarction or unstable angina pectoris within 6 months.
  • Severe pulmonary emphysema or pulmonary fibrosis

研究组 & 干预措施

Comparison group

Other

including the number of cases with complete data who underwent surgery using the conventional method.

Conventional surgery

干预措施: Conventional Surgery (Procedure)

Intervention group

Active Comparator

including a convenient sample of about 20 patients which is expected to be recruited, for whom Complete Mesocolic Excision (CME) and Central Vascular Ligation (CVL) will be done.

Complete mesocolic excision with central vascular ligation

干预措施: Complete mesocolic excision with central vascular ligation (Procedure)

结局指标

主要结局

Lymph nodes harvest

时间窗: Day of surgery

Number of retrieved lymph nodes

次要结局

  • Operative outcome(Day of suregry)
  • Postoperative outcome(1 month)
  • Survival outcome(3 Years)
  • Oncologic outcome(2 years)

研究者

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

Mohamed Abdelkhalek

Assistant Lecturer of Surgical Oncology

Mansoura University

研究点 (4)

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