演題抄録

International Session

開催概要
開催回
第55回・2017年・横浜
 

Clinica Stage0/I期直腸癌に対する腹腔鏡下手術の妥当性に関する第II相試験の最終成績

演題番号 : IS7-5

[筆頭演者]
山本 聖一郎:10,11 
[共同演者]
伊藤 雅昭:1、奥田 準二:2、藤井 正一:3、山口 茂樹:4、大塚 幸喜:5、坂本 一博:6、國場 幸均:8、伴登 宏行:9、吉村 健一:12、渡邊 昌彦:7

1:国立研究開発法人国立がん研究センター中央病院・下部消化管外科、2:大阪医科大学・附属病院・外科、3:横浜市立大学・附属市民総合医療センター・外科、4:埼玉医科大学・国際医療センター・下部消化管外科、5:岩手医科大学・附属病院・外科、6:順天堂大学・医学部附属順天堂医院・下部消化管外科、7:北里大学・病院・外科、8:京都府立医科大学・附属病院・外科、9:石川県立中央病院・外科、10:国立研究開発法人国立がん研究センター中央病院・外科、11:平塚市民病院・外科、12:金沢大学・先端医療開発センター

 

Aim. To examine the technical and oncological feasibility of laparoscopic surgery for rectal carcinoma, we conducted a phase II trial to evaluate laparoscopic surgery for stage 0/I rectal carcinoma in patients with a preoperative diagnosis of stage 0/I rectal carcinoma. The previously reported surgical outcomes demonstrated that laparoscopic surgery can be used for safe and radical resection of clinical stage 0/I rectal carcinoma without increasing short-term surgical and oncological risks. Here, we report to the long-term survival data from the trial.
Methods. Accredited surgeons from 43 institutions in Japan participated in the study. Eligibility criteria included histologically proven rectal carcinoma; clinical stage 0/I; tumor size 8 cm or smaller; patient age 20-75 years; no bowel obstruction; written informed consent. Patients were registered preoperatively. The planned sample size was 490. Surgical outcomes were evaluated. The primary endpoint is overall survival. Overall survival rate was calculated according to the distribution of pathological disease stages in the analysis set.
Results. A total of 495 patients were registered between February 2008 and August 2010. Five patients were ineligible after registration. Five-year overall survival was 96.6 %( (95%CI 94.6%-97.9%), and was significantly better than expected (81.1%) (p<0.0001).
Conclusion. Laparoscopic surgery can be performed safely in patients with clinical stage 0/I rectal carcinoma.

キーワード

臓器別:大腸・小腸

手法別:Clinical Trial (臨床試験)

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