Laparoscopic Ileocecal-Sparing Right Hemicolectomy for Cancer of the Hepatic Flexure and Proximal Transverse Colon -- A Prospective, Multicenter Randomized Control Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 568
- 试验地点
- 29
- 主要终点
- 3-year disease free survival
研究概览
简要总结
The goal of this clinical trial is to compare the long-term outcomes of Laparoscopic Ileocecal-Sparing Right Hemicolectomy(LISH) compared to traditional laparoscopic right hemicolectomy(TRH) in the treatment of hepatic flexure colon cancer and proximal transverse colon cancer.
详细描述
This study is a prospective, multicenter, open-labeled, randomized controlled clinical trial. The enrolled patients will be randomly assigned to either the LISH or TRH group in a 1:1 ratio and will receive the corresponding surgery. The primary endpoint: 3-year disease free survival. The second endpoint: 30-day perioperative complications, pathological outcomes (specimen quality, positive resection margin rate, number of lymph nodes retrieved, and lymph node positivity rate), histological prognostic indicators (planned for superiority testing: 1-, 3-, and 5-year rates of newly detected polyps and adenomas on colonoscopy), quality of life (planned for superiority testing: Gastrointestinal Symptom Rating Scale [GSRS] score and EQ-5D-5L score), and 5-year overall survival (OS).
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
- 否
入选标准
- •Age between 18-75 years old
- •ASA classification ≤III
- •Colon adenocarcinoma confirmed by endoscopy and pathological biopsy
- •Enhanced abdominal CT indicating the primary lesion is located in the hepatic flexure of the colon or proximal transverse colon (proximal 1/3 of the transverse colon)
- •Preoperative clinical staging: TanyNanyM0
- •Patients able to understand the study protocol, willing to participate in the research, and providing written informed consent
排除标准
- •Preoperative examination indicates synchronous multiple primary colorectal cancers or other diseases requiring bowel segment resection
- •Preoperative imaging or intraoperative exploration reveals: 1) tumor involving surrounding organs requiring combined organ resection; 2) presence of distant metastasis; 3) inability to perform R0 resection; 4) fused and fixed lymph nodes at the root of the ileocolic vessels
- •Additional radical surgery following Endoscopic Mucosal Resection (EMR) and Endoscopic Submucosal Dissection (ESD) procedures
- •History of any other malignant tumor within the last 5 years or familial adenomatous polyposis, except for cured in situ cervical cancer, basal cell carcinoma, papillary thyroid carcinoma, or skin squamous cell carcinoma
- •Presence of bowel obstruction, bowel perforation, or intestinal bleeding requiring emergency surgery
- •Patients unsuitable for or unable to tolerate laparoscopic surgery
- •Pregnant or lactating women
- •Patients with a history of psychiatric disorders
- •Patients who have received neoadjuvant therapy prior to surgery
- •Patients deemed unsuitable for the study by MDT discussion
- •Patients unable to understand the study's conditions and objectives, and refusing to sign informed consent.
研究组 & 干预措施
LISH （Laparoscopic Ileocecal-Sparing Right Hemicolectomy）group
In LISH group, patients suffering from cancer of the hepatic flexure and proximal transverse colon will be undergoing a novel radical right hemicolectomy technique that allows for the preservation of the ileocecal region.
干预措施: LISH （Laparoscopic Ileocecal-Sparing Right Hemicolectomy） (Procedure)
TRH （Traditional Right Hemicolectomy）group
In TRH group, patients suffering from cancer of the hepatic flexure and proximal transverse colon will be undergoing the traditional radical right hemicolectomy.
干预措施: TRH（Traditional Laparoscopic Right Hemicolectomy） (Procedure)
结局指标
主要结局
3-year disease free survival
时间窗: 3 years
the time from enrollment until disease relapse or death from any cause 3 years after surgery
次要结局
- Scores from the EQ-5D-5L Quality of Life Scale(3 years)
- 5-year overall survival rate (OS)(5 years)
- Perioperative complications(up to 30 days after surgery)
- Quality of the specimen(up to 2 weeks after surgery)
- Incidence rates of polyps and adenomas(5 years)
- Scores of quality of life(3 years)
研究者
Ding Ke-Feng
Professor
Zhejiang University