Trial Title:
LISH Trial for the Hepatic Flexure and Proximal Transverse Colon Cancer
NCT ID:
NCT05923255
Condition:
Hepatic Flexure Colon Cancer
Proximal Transverse Colon Cancer
Conditions: Official terms:
Colonic Neoplasms
Conditions: Keywords:
hepatic flexure colon cancer
proximal transverse colon cancer
ileocecus-sparing
laparoscopic right hemicolectomy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
LISH （Laparoscopic Ileocecal-Sparing Right Hemicolectomy）
Description:
Preserve the ileocolic blood vessels, and perform dissection of lymph node groups 203,
202, and 201d along the root of ICV(Ileocolic artery)/ICA(Ileocolic vein). Group 201d
lymph nodes are defined as the distal lymph nodes of the ileocolic vessels (colonic
branch). Use an intracavitary cutting and sealing device to transect the proximal colon
along the predetermined margin, and transect the transverse colon at 10cm distal to the
tumor. Perform ileocecal-transverse colonic anastomosis.
Arm group label:
LISH （Laparoscopic Ileocecal-Sparing Right Hemicolectomy）group
Intervention type:
Procedure
Intervention name:
TRH（Traditional Laparoscopic Right Hemicolectomy）
Description:
Transect the root of the ileocolic vessels and perform dissection of lymph node groups
203, 202, and 201; sever the roots of the right colic and middle colic vessels, and clear
the surrounding lymphoadipose tissue (lymph node groups 211/212/213 and 221/222/223).
Transect the transverse colon 10cm distal to the tumor and cut the terminal ileum 10cm
from the ileocecal junction. Perform ileum-to-transverse colon anastomosis.
Arm group label:
TRH （Traditional Right Hemicolectomy）group
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)
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
the First Affiliated Hospital of Bengbu Medical Collage
Address:
City:
Bengbu
Country:
China
Status:
Recruiting
Contact:
Last name:
Muling Liu, phD
Investigator:
Last name:
Muling Liu, phD
Email:
Principal Investigator
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100000
Country:
China
Status:
Recruiting
Contact:
Last name:
Aiwen Wu, PhD
Contact backup:
Last name:
Xiangqian Su, PhD
Investigator:
Last name:
Aiwen Wu, PhD
Email:
Principal Investigator
Investigator:
Last name:
Xiangqian Su, PhD
Email:
Principal Investigator
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yi Xiao, PhD
Investigator:
Last name:
Yi Xiao, PhD
Email:
Principal Investigator
Facility:
Name:
Cancer Hospital Academy of medicine Scenice
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Qian Liu, phD
Contact backup:
Last name:
Xishan Wang
Investigator:
Last name:
Qian Liu, phD
Email:
Principal Investigator
Investigator:
Last name:
Xishan Wang, phD
Email:
Principal Investigator
Facility:
Name:
the First Affiliated Hospital of Chongqing Medical Collage
Address:
City:
Chongqing
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhengqiang Wei, phD
Investigator:
Last name:
Zhengqiang Wei, phD
Email:
Principal Investigator
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Status:
Recruiting
Contact:
Last name:
Chunkang Yang, PhD
Investigator:
Last name:
Chunkang Yang, MD
Email:
Principal Investigator
Facility:
Name:
Fujian Hospital Medical Union University
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Status:
Recruiting
Contact:
Last name:
Pan Chi
Investigator:
Last name:
Pan Chi, M.D.
Email:
Principal Investigator
Facility:
Name:
The First Affiliated Hospital of Xiamen University
Address:
City:
Xiamen
Country:
China
Status:
Not yet recruiting
Facility:
Name:
The sixth Affiliated Hospital, Sun Yat-sen University
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Facility:
Name:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technolog
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Contact:
Last name:
Kaixiong Tao, phD
Investigator:
Last name:
Kaixiong Tao, phD
Email:
Principal Investigator
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhigang Xiao, phD
Contact backup:
Last name:
Zhongcheng Huang, phD
Investigator:
Last name:
Zhigang Xiao, phD
Email:
Principal Investigator
Facility:
Name:
Jiangsu province hospital
Address:
City:
Nanjing
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yueming Sun, phD
Investigator:
Last name:
Yueming Sun, phD
Email:
Principal Investigator
Facility:
Name:
Nanjing Drum Tower Hospital
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Contact:
Last name:
Gang Chen, phD
Investigator:
Last name:
Gang Chen, phD
Email:
Principal Investigator
Facility:
Name:
The First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Taiyuan Li, phD
Investigator:
Last name:
Taiyuan Li, phD
Email:
Principal Investigator
Facility:
Name:
The Second Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Country:
China
Status:
Recruiting
Contact:
Last name:
Shengxun Mao, phD
Investigator:
Last name:
Shengxun Mao, phD
Email:
Principal Investigator
Facility:
Name:
Changhai Hospital of Shanghai
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Zhang
Investigator:
Last name:
Wei Zhang, MD
Email:
Principal Investigator
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Ye Xu, phD
Contact backup:
Last name:
Xinxiang Li, phD
Investigator:
Last name:
Ye Xu, phD
Email:
Principal Investigator
Investigator:
Last name:
Xinxiang Li, phD
Email:
Principal Investigator
Facility:
Name:
Renji Hospital Affiliated of The Shanghai Jiao Tong University Medical School
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Ming Zhong, phD
Investigator:
Last name:
Ming Zhong, phD
Email:
Principal Investigator
Facility:
Name:
Ruijin Hospital Affiliated of The Shanghai Jiao Tong University Medical School
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Bo Feng, phD
Investigator:
Last name:
Bo Feng, phD
Email:
Principal Investigator
Facility:
Name:
Sichuan Cancer Hospital
Address:
City:
Chengdu
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jin Yan, phD
Investigator:
Last name:
Jin Yan, phD
Email:
Principal Investigator
Facility:
Name:
West China Hospital of Sichuang University
Address:
City:
Chengdu
Country:
China
Status:
Recruiting
Contact:
Last name:
Ziqiang Wang, phD
Investigator:
Last name:
Ziqiang Wang, phD
Email:
Principal Investigator
Facility:
Name:
The Cancer Hospital Affiliated of The Xingjiang University Medical School
Address:
City:
Xinjiang
Country:
China
Status:
Recruiting
Contact:
Last name:
Haijiang Wang, phD
Investigator:
Last name:
Haijiang Wang, phD
Email:
Principal Investigator
Facility:
Name:
Yunan Cancer Hospital
Address:
City:
Kunming
Country:
China
Status:
Recruiting
Contact:
Last name:
Yunfeng Li, phD
Investigator:
Last name:
Yunfeng Li, phD
Email:
Principal Investigator
Facility:
Name:
Second Affiliated Hospital Zhejiang University College of Medicine
Address:
City:
Hangzhou
Zip:
310999
Country:
China
Status:
Recruiting
Contact:
Last name:
Ke-Feng Ding, phD/MD
Phone:
86-571-87784827
Email:
dingkefeng@zju.edu.cn
Investigator:
Last name:
Ke-Feng Ding, phD/MD
Email:
Principal Investigator
Facility:
Name:
Sir Run Run Shaw Hospital, Zhejiang University School of medicien
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Xuefeng Huang, phD
Investigator:
Last name:
Xuefeng Huang, phD
Email:
Principal Investigator
Facility:
Name:
The First Affiliated Hospital, Zhejiang University school of Medicine
Address:
City:
Hangzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Wenbin Chen, phD
Investigator:
Last name:
Wenbin Chen, phD
Email:
Principal Investigator
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Haixing Ju, phD
Investigator:
Last name:
Haixing Ju, phD
Email:
Principal Investigator
Facility:
Name:
Jinhua Municipal Central Hospital
Address:
City:
Jinhua
Country:
China
Status:
Recruiting
Contact:
Last name:
Jinlin Du, phD
Investigator:
Last name:
Jinlin Du, phD
Email:
Principal Investigator
Facility:
Name:
Ningbo No.2 Hospital
Address:
City:
Ningbo
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaoyu Dai, phD
Investigator:
Last name:
Xiaoyu Dai, phD
Email:
Principal Investigator
Facility:
Name:
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Address:
City:
Guangzhou
Country:
China
Status:
Not yet recruiting
Start date:
May 14, 2023
Completion date:
May 14, 2031
Lead sponsor:
Agency:
Zhejiang University
Agency class:
Other
Source:
Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05923255
