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临床试验/NCT01112046
NCT01112046Unknown3 期

Endoscopic Submucosal Dissection Versus Laparoscopic Resection for Early Colorectal Neoplasms: A Prospective Randomized Trial

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2010年4月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
入组人数
124
试验地点
1
主要终点
Short-term morbidity

研究概览

简要总结

This is a prospective randomized trial that aimed to compare the short-term clinical outcomes and systemic inflammatory/cytokine responses of endoscopic submucosal dissection versus laparoscopic resection for early colorectal neoplasms that are not amenable to en bloc endoscopic resection with conventional techniques.

详细描述

Colonoscopy plays an increasingly important role in the diagnosis and treatment of colorectal pathologies. The recent progress in endoscopic technologies and interest in colorectal cancer screening have enabled the diagnosis of a larger number of early colorectal neoplasms, including benign polyps and early cancers. Colonoscopic polypectomy remains the cornerstone of therapy for the majority of colorectal polyps and helps prevent colorectal cancer. However, if colorectal neoplasms are too large or cannot be removed "en bloc" endoscopically, operative procedures are required to reduce risks of incomplete removal and local recurrence. Laparoscopic resection represents a minimally invasive alternative for treating colorectal neoplasms that are not amenable to en bloc endoscopic resection. However, laparoscopic surgery has to be done under general anesthesia, is associated with operative morbidity, and is expensive.

Endoscopic submucosal dissection (ESD) is a revolutionary endoscopic procedure that enables en bloc resection of large gastrointestinal tumors, irrespective of the size of the lesion. ESD, which was pioneered in Japan for the treatment of early gastric neoplasms, has now been successfully applied to the colon and rectum. ESD has been shown by recent studies to be a safe and effective resection technique for large early colorectal neoplasms. However, no report can be found in the literature comparing ESD and laparoscopic resection for early colorectal neoplasms that are not amenable to en bloc endoscopic resection with conventional techniques. Furthermore, it remains unclear whether ESD is less invasive than laparoscopic surgery in terms of systemic inflammatory and cytokine responses, and all these may have implications for cancer recurrence.

We propose to conduct a prospective randomized trial to compare the short-term clinical outcomes and systemic inflammatory/cytokine responses of ESD versus laparoscopic resection for early colorectal neoplasms that are not amenable to en bloc endoscopic resection with conventional techniques. The overall costs of the two therapeutic approaches will also be compared. Findings of this proposed project may provide evidence-based clarification of the efficacy and safety of ESD in treating early colorectal neoplasms. We hypothesize that ESD is associated with lower morbidity, earlier recovery, shorter hospital stay, and lower costs when compared with laparoscopic resection. A faster recovery and earlier discharge after ESD may reduce financial burden to the hospital and health care system. The results of this proposed project may have a significant impact on the future treatment strategy for early colorectal neoplasms, and may provide new insights into the systemic inflammatory responses of ESD.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients diagnosed with early colorectal neoplasms >/= 2 cm in size in the colon or upper rectum (>/= 15 cm above the anal verge) that are deemed not feasible for en bloc resection with conventional polypectomy or EMR as judged by 2 experienced endoscopists,
  • •Age of patients >18 years,
  • •Patients with American Society of Anesthesiologists (ASA) grading I-III,
  • •Informed consent available

排除标准

  • •Presence of endoscopic signs of massive submucosal invasion (including excavated/depressed morphology or Kudo's pit pattern Type V),
  • •Endosonographic evidence of deep invasion,
  • •Unfavorable histopathologic features on biopsy (including mucinous cancer, poor differentiation, and gross submucosal invasion),
  • •Patients with other synchronous colorectal neoplasms in addition to the index neoplasm that are not amenable to complete endoscopic removal, neoplasms occupying more than half circumference of the colonic wall,
  • •Patients with recurrence from previous endoscopic mucosal resection or ESD,
  • •Patients with known metastatic disease,
  • •Patients with previous history of abdominal surgery, and patients with non-correctable coagulopathy

研究组 & 干预措施

Endoscopic submucosal dissection

Experimental

干预措施: Endoscopic submucosal dissection (Procedure)

Laparoscopic resection

Active Comparator

干预措施: Laparoscopic resection (Procedure)

结局指标

主要结局

Short-term morbidity

时间窗: Up to 1 month

次要结局

  • Systemic cytokine and C-reactive protein levels(Up to 5 days)
  • Post-ESD/surgery recovery(Up to 1 month)
  • Quality of life(Up to 1 year)
  • Direct and indirect medical costs(Up to 1 year)
  • Local recurrence(Within 5 years after ESD/surgery)

研究者

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

Simon S. M. Ng

Professor

Chinese University of Hong Kong

研究点 (1)

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