LISH Trial for the Hepatic Flexure and Proximal Transverse Colon Cancer
NCT ID: NCT05923255
Last Updated: 2025-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
568 participants
INTERVENTIONAL
2023-05-14
2031-05-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LISH （Laparoscopic Ileocecal-Sparing Right Hemicolectomy）group
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.
LISH （Laparoscopic Ileocecal-Sparing Right Hemicolectomy）
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.
TRH （Traditional Right Hemicolectomy）group
In TRH group, patients suffering from cancer of the hepatic flexure and proximal transverse colon will be undergoing the traditional radical right hemicolectomy.
TRH（Traditional Laparoscopic Right Hemicolectomy）
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.
Interventions
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LISH （Laparoscopic Ileocecal-Sparing Right Hemicolectomy）
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.
TRH（Traditional Laparoscopic Right Hemicolectomy）
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Zhejiang University
OTHER
Responsible Party
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Ding Ke-Feng
Professor
Principal Investigators
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Kefeng Ding, PhD
Role: PRINCIPAL_INVESTIGATOR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Locations
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the First Affiliated Hospital of Bengbu Medical Collage
Bengbu, Anhui, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Cancer Hospital Academy of medicine Scenice
Beijing, Beijing Municipality, China
the First Affiliated Hospital of Chongqing Medical Collage
Chongqing, Chongqing Municipality, 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
Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, China
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 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
Shandong Cancer Hospital
Jinan, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Renji Hospital Affiliated of The Shanghai Jiao Tong University Medical School
Shanghai, Shanghai Municipality, China
Ruijin Hospital Affiliated of The Shanghai Jiao Tong University Medical School
Shanghai, Shanghai Municipality, 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
Countries
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Central Contacts
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Facility Contacts
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Muling Liu, phD
Role: primary
Aiwen Wu, PhD
Role: primary
Xiangqian Su, PhD
Role: backup
Yi Xiao, PhD
Role: primary
Qian Liu, phD
Role: primary
Xishan Wang
Role: backup
Zhengqiang Wei, phD
Role: primary
Chunkang Yang, PhD
Role: primary
Pan Chi
Role: primary
Han Fanghai, Prof.
Role: primary
Wu Xiaojian
Role: primary
Kaixiong Tao, phD
Role: primary
Zhigang Xiao, phD
Role: primary
Zhongcheng Huang, phD
Role: backup
Yueming Sun, phD
Role: primary
Gang Chen, phD
Role: primary
Taiyuan Li, phD
Role: primary
Shengxun Mao, phD
Role: primary
Sun Yanlai, Prof.
Role: primary
Zhou Yanbin, Prof.
Role: primary
Wei Zhang
Role: primary
Ye Xu, phD
Role: primary
Xinxiang Li, phD
Role: backup
Ming Zhong, phD
Role: primary
Bo Feng, phD
Role: primary
Jin Yan, phD
Role: primary
Ziqiang Wang, phD
Role: primary
Haijiang Wang, phD
Role: primary
Yunfeng Li, phD
Role: primary
Xuefeng Huang, phD
Role: primary
Wenbin Chen, phD
Role: primary
Haixing Ju, phD
Role: primary
Jinlin Du, phD
Role: primary
Xiaoyu Dai, phD
Role: primary
Other Identifiers
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CRCCZ-S03
Identifier Type: -
Identifier Source: org_study_id
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