Comparing two surgical methods for colon cancer treatment
Laparoscopic Ileocecal-Sparing Right Hemicolectomy for Cancer of the Hepatic Flexure and Proximal Transverse Colon -- A Prospective, Multicenter Randomized Control Clinical Trial
This study is testing whether a new type of colon cancer surgery called Laparoscopic Ileocecal-Sparing Right Hemicolectomy can lead to better long-term results than the traditional surgery for patients with specific types of colon cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 568 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Zhejiang University Academic / other |
| Locations | 29 sites (Bengbu, Anhui and 28 other locations) |
| Trial ID | NCT05923255 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the long-term outcomes of Laparoscopic Ileocecal-Sparing Right Hemicolectomy (LISH) versus Traditional Laparoscopic Right Hemicolectomy (TRH) in patients with hepatic flexure and proximal transverse colon cancer. It is a prospective, multicenter, open-labeled, randomized controlled trial where participants will be randomly assigned to one of the two surgical approaches. The primary endpoint is the 3-year disease-free survival rate, while secondary endpoints include postoperative complications, pathology-related indicators, and the 5-year overall survival rate. The study seeks to determine if LISH offers better outcomes compared to TRH.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with confirmed colon adenocarcinoma located in the hepatic flexure or proximal transverse colon.
Not a fit: Patients with synchronous multiple primary colorectal cancers or those requiring additional radical surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and survival rates for patients with specific types of colon cancer.
How similar studies have performed: Other studies have shown promising results with laparoscopic techniques, but this specific comparison of LISH and TRH is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age between 18-75 years old 2. ASA classification ≤III 3. Colon adenocarcinoma confirmed by endoscopy and pathological biopsy 4. 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) 5. Preoperative clinical staging: TanyNanyM0 6. Patients able to understand the study protocol, willing to participate in the research, and providing written informed consent Exclusion Criteria: 1. Preoperative examination indicates synchronous multiple primary colorectal cancers or other diseases requiring bowel segment resection 2. 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 3. Additional radical surgery following Endoscopic Mucosal Resection (EMR) and Endoscopic Submucosal Dissection (ESD) procedures 4. 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 5. Presence of bowel obstruction, bowel perforation, or intestinal bleeding requiring emergency surgery 6. Patients unsuitable for or unable to tolerate laparoscopic surgery 7. Pregnant or lactating women 8. Patients with a history of psychiatric disorders 9. Patients who have received neoadjuvant therapy prior to surgery 10. Patients deemed unsuitable for the study by MDT discussion 11. Patients unable to understand the study's conditions and objectives, and refusing to sign informed consent.
Where this trial is running
Bengbu, Anhui and 28 other locations
- the First Affiliated Hospital of Bengbu Medical Collage — Bengbu, Anhui, China (Recruiting)
- Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Cancer Hospital Academy of medicine Scenice — Beijing, Beijing Municipality, China (Recruiting)
- the First Affiliated Hospital of Chongqing Medical Collage — Chongqing, Chongqing Municipality, China (Recruiting)
- Fujian Cancer Hospital — Fuzhou, Fujian, China (Recruiting)
- Fujian Hospital Medical Union University — Fuzhou, Fujian, China (Recruiting)
- The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (Not_yet_recruiting)
- Guangdong Second Provincial General Hospital — Guangzhou, Guangdong, China (Recruiting)
- The Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technolog — Wuhan, Hubei, China (Recruiting)
- People's Hospital of Hunan Province — Changsha, Hunan, China (Recruiting)
- Jiangsu province hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
- Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (Recruiting)
- The Second Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
- Shandong Cancer Hospital — Jinan, Shandong, China (Recruiting)
- The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (Recruiting)
- Changhai Hospital of Shanghai — Shanghai, Shanghai Municipality, China (Recruiting)
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
- Ruijin Hospital Affiliated of The Shanghai Jiao Tong University Medical School — Shanghai, Shanghai Municipality, China (Recruiting)
- The first affiliated hospital of xi'an jiaotong university — Xi’an, Shanxi, China (Recruiting)
- West China Hospital of Sichuang University — Chengdu, Sichuan, China (Recruiting)
- The Cancer Hospital Affiliated of The Xingjiang University Medical School — Xinjiang, Xinjiang, China (Recruiting)
- Yunnan Cancer Hospital — Kunming, Yunnan, China (Recruiting)
- Second Affiliated Hospital Zhejiang University College of Medicine — Hangzhou, Zhejiang, China (Recruiting)
- Sir Run Run Shaw Hospital, Zhejiang University School of medicien — Hangzhou, Zhejiang, China (Recruiting)
- Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Not_yet_recruiting)
- Jinhua Municipal Central Hospital — Jinhua, Zhejiang, China (Recruiting)
- Ningbo No.2 Hospital — Ningbo, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Kefeng Ding, PhD — Second Affiliated Hospital, School of Medicine, Zhejiang University
- Study coordinator: Kefeng Ding, PhD
- Email: dingkefeng@zju.edu.cn
- Phone: 86-571-87784720
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.