Comparing two surgical methods for colon cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Kefeng Ding, PhD — Second Affiliated Hospital, Zhejiang University, School of Medicine
• Study coordinator: Kefeng Ding, PhD
• Email: dingkefeng@zju.edu.cn
• Phone: 86-571-87784720

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.