LISH Trial for the Hepatic Flexure and Proximal Transverse Colon Cancer
- Conditions
- Proximal Transverse Colon CancerHepatic Flexure Colon Cancer
- Interventions
- Procedure: TRH（Traditional Laparoscopic Right Hemicolectomy）Procedure: LISH （Laparoscopic Ileocecal-Sparing Right Hemicolectomy）
- Registration Number
- NCT05923255
- Lead Sponsor
- Zhejiang University
- Brief Summary
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.
- Detailed Description
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: (1)90-day postoperative complications; (2)Pathology-related indicators, including positive margin rate, number of harvested lymph nodes and lymph node metastasis rate;(3) 5-year overall survival rate (OS)
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 568
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TRH （Traditional Right Hemicolectomy）group TRH（Traditional Laparoscopic Right Hemicolectomy） In TRH group, patients suffering from cancer of the hepatic flexure and proximal transverse colon will be undergoing the traditional radical right hemicolectomy. LISH （Laparoscopic Ileocecal-Sparing Right Hemicolectomy）group LISH （Laparoscopic Ileocecal-Sparing Right Hemicolectomy） 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.
- Primary Outcome Measures
Name Time Method 3-year disease free survival 3 years the time from enrollment until disease relapse or death from any cause 3 years after surgery
- Secondary Outcome Measures
Name Time Method Length of resected specimen up to 2 weeks after surgery On the basis of the anterior and posterior photographs, the length of resected specimen were measured.
Postoperative complications up to 30 days after surgery Complications occurring within 30 days after surgery, classified according to the Clavien-Dindo system, including intraoperative, short-term, and long-term postoperative complications.Index (CCI) will be recorded
Metastasis rate of harvested lymph nodes up to 2 weeks after surgery according to the pathological report
Quality of CME (complete mesocolic excision) up to 2 weeks after surgery After the specimen had been harvested, photographs of the anterior and posterior aspects of the specimens were uploaded to the electronic data capture system. On the basis of the anterior and posterior photographs, the specimens were classified into three groups of the quality of CME: grade I, intact mesocolon; grade II laceration in the mesocolon; and grade III laceration in the mesocolon reaching the bowel.
Incidence rates of polyps 5 years the incidence rates of polyps as seen on colonoscopy at 1, 3 and 5 years after surgery respectively.
Scores from the Gastrointestinal Symptom Rating Scale (GSRS) 3 years scores from the Gastrointestinal Symptom Rating Scale (GSRS) at 1, 2, and 3 years after surgery respectively.
Scores from the EQ-5D-5L Quality of Life Scale 3 years scores from the EQ-5D-5L Quality of Life Scale at 1, 2, and 3 years after surgery respectively.
Resection margins distance up to 2 weeks after surgery On the basis of the anterior and posterior photographs, the distal and proximal resection margins distance of the resected intestinal specimen were measured.
Vascular pedicle length of resected specimen up to 2 weeks after surgery On the basis of the anterior and posterior photographs, the vascular pedicle length of the resected intestinal specimen were measured.
Positive margin rate up to 2 weeks after surgery positive margin rate of resected specimen according to the pathological report
Incidence rates of adenomas 5 years the incidence rates of adenomas as seen on colonoscopy at 1, 3 and 5 years after surgery respectively.
5-year overall survival rate (OS) 5 years The proportion of patients who survived 5 years after surgery, taking into account any cause of death.
Trial Locations
- Locations (34)
Guangdong Second Provincial General Hospital
🇨🇳Guangzhou, Guangdong, China
The Sixth Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Shandong Cancer Hospital
🇨🇳Jinan, Shandong, China
The Affiliated Hospital of Qingdao University
🇨🇳Qingdao, Shandong, China
the First Affiliated Hospital of Bengbu Medical Collage
🇨🇳Bengbu, Anhui, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Cancer Hospital Academy of medicine Scenice
🇨🇳Beijing, Beijing, China
the First Affiliated Hospital of Chongqing Medical Collage
🇨🇳Chongqing, Chongqing, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China
Fujian Hospital Medical Union University
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
The sixth Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangzhou, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technolog
🇨🇳Wuhan, Hubei, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Jiangsu province hospital
🇨🇳Nanjing, Jiangsu, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Changhai Hospital of Shanghai
🇨🇳Shanghai, Shanghai, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Renji Hospital Affiliated of The Shanghai Jiao Tong University Medical School
🇨🇳Shanghai, Shanghai, China
Ruijin Hospital Affiliated of The Shanghai Jiao Tong University Medical School
🇨🇳Shanghai, Shanghai, China
Sichuan Cancer Hospital
🇨🇳Chengdu, Sichuan, China
West China Hospital of Sichuang University
🇨🇳Chengdu, Sichuan, China
The Cancer Hospital Affiliated of The Xingjiang University Medical School
🇨🇳Xinjiang, Xinjiang, China
Yunan Cancer Hospital
🇨🇳Kunming, Yunnan, China
Second Affiliated Hospital Zhejiang University College of Medicine
🇨🇳Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, Zhejiang University School of medicien
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital, Zhejiang University school of Medicine
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Jinhua Municipal Central Hospital
🇨🇳Jinhua, Zhejiang, China
Ningbo No.2 Hospital
🇨🇳Ningbo, Zhejiang, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
🇨🇳Guangzhou, China