Clinical trial NCT05923255: LISH Trial for the Hepatic Flexure and Proximal Transverse Colon Cancer
Official title: Laparoscopic Ileocecal-Sparing Right Hemicolectomy for Cancer of the Hepatic Flexure and Proximal Transverse Colon -- A Prospective, Multicenter Randomized Control Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatic Flexure Colon Cancer
Proximal Transverse Colon Cancer
Keywords: hepatic flexure colon cancer
proximal transverse colon cancer
ileocecus-sparing
laparoscopic right hemicolectomy
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 568
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility 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.

Primary outcomes:
measure: 3-year disease free survival
timeFrame: 3 years
Secondary outcomes:
measure: Postoperative complications
timeFrame: up to 30 days after surgery
measure: Metastasis rate of harvested lymph nodes
timeFrame: up to 2 weeks after surgery
measure: Quality of CME (complete mesocolic excision)
timeFrame: up to 2 weeks after surgery
measure: Length of resected specimen
timeFrame: up to 2 weeks after surgery
measure: Resection margins distance
timeFrame: up to 2 weeks after surgery
measure: Vascular pedicle length of resected specimen
timeFrame: up to 2 weeks after surgery
measure: Positive margin rate
timeFrame: up to 2 weeks after surgery
measure: Incidence rates of polyps
timeFrame: 5 years
measure: Incidence rates of adenomas
timeFrame: 5 years
measure: Scores from the Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: 3 years
measure: Scores from the EQ-5D-5L Quality of Life Scale
timeFrame: 3 years
measure: 5-year overall survival rate (OS)
timeFrame: 5 years
Other outcomes:
measure: Conversion Rate from Laparoscopic to Open Surgery
timeFrame: Intraoperative period
measure: LISH Surgery Completion Rate
timeFrame: Intraoperative period
measure: Minimal Residual Disease (MRD) via Circulating Tumor DNA (ctDNA)
timeFrame: Preoperative (7 days), postoperative (7 days), and 3 months post-surgery
measure: Short- and Long-Term Changes in Gut Microecology
timeFrame: Preoperative, postoperative 3 months, 6 months and 12 months
measure: Glycemic Metabolic Indicators - Hemoglobin A1c (HbA1c)
timeFrame: Preoperative, 3 months, 6 months, and 12 months post-surgery
measure: Oral Glucose Tolerance Test (OGTT)
timeFrame: Preoperative, 3 months, 6 months, and 12 months post-surgery
measure: Insulin Resistance (HOMA-IR)
timeFrame: Preoperative, 3 months, 6 months, and 12 months post-surgery
Locations:
city: Bengbu
country: China
facility: the First Affiliated Hospital of Bengbu Medical Collage
state: Anhui
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Cancer Hospital Academy of medicine Scenice
state: Beijing
city: Chongqing
country: China
facility: the First Affiliated Hospital of Chongqing Medical Collage
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Fuzhou
country: China
facility: Fujian Hospital Medical Union University
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Second Provincial General Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: The sixth Affiliated Hospital, Sun Yat-sen University
state: Guangzhou
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technolog
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: Jiangsu province hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Changhai Hospital of Shanghai
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Shanghai
country: China
facility: Renji Hospital Affiliated of The Shanghai Jiao Tong University Medical School
state: Shanghai
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated of The Shanghai Jiao Tong University Medical School
state: Shanghai
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
state: Sichuan
city: Chengdu
country: China
facility: West China Hospital of Sichuang University
state: Sichuan
city: Xinjiang
country: China
facility: The Cancer Hospital Affiliated of The Xingjiang University Medical School
state: Xinjiang
city: Kunming
country: China
facility: Yunan Cancer Hospital
state: Yunnan
city: Hangzhou
country: China
facility: Second Affiliated Hospital Zhejiang University College of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University School of medicien
state: Zhejiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University school of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Jinhua
country: China
facility: Jinhua Municipal Central Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo No.2 Hospital
state: Zhejiang
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Kefeng Ding, PhD
role: PRINCIPAL_INVESTIGATOR
References: