LISH Trial for the Hepatic Flexure and Proximal Transverse Colon Cancer

Laparoscopic Ileocecal-Sparing Right Hemicolectomy for Cancer of the Hepatic Flexure and Proximal Transverse Colon -- A Prospective, Multicenter Randomized Control Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatic Flexure Colon Cancer; Proximal Transverse Colon Cancer
• Intervention / Treatment: Procedure: LISH （Laparoscopic Ileocecal-Sparing Right Hemicolectomy）; Procedure: TRH（Traditional Laparoscopic Right Hemicolectomy）

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: 30-day perioperative complications, pathological outcomes (specimen quality, positive resection margin rate, number of lymph nodes retrieved, and lymph node positivity rate), histological prognostic indicators (planned for superiority testing: 1-, 3-, and 5-year rates of newly detected polyps and adenomas on colonoscopy), quality of life (planned for superiority testing: Gastrointestinal Symptom Rating Scale [GSRS] score and EQ-5D-5L score), and 5-year overall survival (OS).

• Study Type: Interventional
• Enrollment (Estimated): 568
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kefeng Ding, PhD; Phone Number: 86-571-87784720; Email: dingkefeng@zju.edu.cn

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China
      • Recruiting
      • the First Affiliated Hospital of Bengbu Medical Collage
      • Contact: Muling Liu, phD
      • Principal Investigator: Muling Liu, phD
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100000
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Yi Xiao, PhD
      • Principal Investigator: Yi Xiao, PhD
    • Beijing, Beijing Municipality, China, 100000
      • Recruiting
      • Beijing Cancer Hospital
      • Contact: Aiwen Wu, PhD
      • Contact: Xiangqian Su, PhD
      • Principal Investigator: Aiwen Wu, PhD
      • Principal Investigator: Xiangqian Su, PhD
    • Beijing, Beijing Municipality, China
      • Recruiting
      • Cancer Hospital Academy of medicine Scenice
      • Contact: Xishan Wang
      • Contact: Qian Liu, phD
      • Principal Investigator: Qian Liu, phD
      • Principal Investigator: Xishan Wang, phD
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China
      • Recruiting
      • the First Affiliated Hospital of Chongqing Medical Collage
      • Contact: Zhengqiang Wei, phD
      • Principal Investigator: Zhengqiang Wei, phD
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Fujian Cancer Hospital
      • Contact: Chunkang Yang, PhD
      • Principal Investigator: Chunkang Yang, MD
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Fujian Hospital Medical Union University
      • Contact: Pan Chi
      • Principal Investigator: Pan Chi, M.D.
    • Xiamen, Fujian, China
      • Not yet recruiting
      • The First Affiliated Hospital of Xiamen University
  • Guangdong
    • Guangzhou, Guangdong, China, 510655
      • Recruiting
      • The sixth affiliated hospital of Sun Yat-Sen University
      • Contact: Wu Xiaojian
    • Guangzhou, Guangdong, China, 510317
      • Recruiting
      • Guangdong Second Provincial General Hospital
      • Contact: Han Fanghai, Prof.
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technolog
      • Contact: Kaixiong Tao, phD
      • Principal Investigator: Kaixiong Tao, phD
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • People's Hospital of Hunan Province
      • Contact: Zhigang Xiao, phD
      • Contact: Zhongcheng Huang, phD
      • Principal Investigator: Zhigang Xiao, phD
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Not yet recruiting
      • Jiangsu Province Hospital
      • Contact: Yueming Sun, phD
      • Principal Investigator: Yueming Sun, phD
    • Nanjing, Jiangsu, China
      • Recruiting
      • Nanjing Drum Tower Hospital
      • Contact: Gang Chen, phD
      • Principal Investigator: Gang Chen, phD
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Recruiting
      • The Second Affiliated Hospital of Nanchang University
      • Contact: Shengxun Mao, phD
      • Principal Investigator: Shengxun Mao, phD
  • Shandong
    • Jinan, Shandong, China, 250117
      • Recruiting
      • Shandong Cancer Hospital
      • Contact: Sun Yanlai, Prof.
    • Qingdao, Shandong, China, 266003
      • Recruiting
      • The affiliated hospital of Qingdao university
      • Contact: Zhou Yanbin, Prof.
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: Ye Xu, phD
      • Contact: Xinxiang Li, phD
      • Principal Investigator: Ye Xu, phD
      • Principal Investigator: Xinxiang Li, phD
    • Shanghai, Shanghai Municipality, China, 200433
      • Recruiting
      • Changhai Hospital of Shanghai
      • Principal Investigator: Wei Zhang, MD
      • Contact: Wei Zhang
    • Shanghai, Shanghai Municipality, China
      • Recruiting
      • Ruijin Hospital Affiliated of The Shanghai Jiao Tong University Medical School
      • Contact: Bo Feng, phD
      • Principal Investigator: Bo Feng, phD
  • Shanxi
    • Xi’an, Shanxi, China, 710000
      • Recruiting
      • The First Affiliated Hospital of Xi'an Jiaotong University
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • West China Hospital of Sichuang University
      • Contact: Ziqiang Wang, phD
      • Principal Investigator: Ziqiang Wang, phD
  • Xinjiang
    • Xinjiang, Xinjiang, China
      • Recruiting
      • The Cancer Hospital Affiliated of The Xingjiang University Medical School
      • Contact: Haijiang Wang, phD
      • Principal Investigator: Haijiang Wang, phD
  • Yunnan
    • Kunming, Yunnan, China
      • Recruiting
      • Yunnan Cancer Hospital
      • Contact: Yunfeng Li, phD
      • Principal Investigator: Yunfeng Li, phD
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Not yet recruiting
      • Zhejiang Cancer Hospital
      • Contact: Haixing Ju, phD
      • Principal Investigator: Haixing Ju, phD
    • Hangzhou, Zhejiang, China, 310999
      • Recruiting
      • Second Affiliated Hospital Zhejiang University College of Medicine
      • Contact: Ke-Feng Ding, phD/MD; Phone Number: 86-571-87784827; Email: dingkefeng@zju.edu.cn
      • Principal Investigator: Ke-Feng Ding, phD/MD
      • Contact: Jian Wang, phD/MD; Phone Number: 0571-87784720; Email: wangjian519@zju.edu.cn
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Sir Run Run Shaw Hospital, Zhejiang University School of medicien
      • Contact: Xuefeng Huang, phD
      • Principal Investigator: Xuefeng Huang, phD
    • Jinhua, Zhejiang, China
      • Recruiting
      • Jinhua municipal central hospital
      • Contact: Jinlin Du, phD
      • Principal Investigator: Jinlin Du, phD
    • Ningbo, Zhejiang, China
      • Recruiting
      • Ningbo No.2 Hospital
      • Contact: Xiaoyu Dai, phD
      • Principal Investigator: Xiaoyu Dai, phD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.
Active Comparator: 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year disease free survival	the time from enrollment until disease relapse or death from any cause 3 years after surgery	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scores from the EQ-5D-5L Quality of Life Scale	scores from the EQ-5D-5L Quality of Life Scale at 1, 2, and 3 years after surgery respectively.	3 years
5-year overall survival rate (OS)	The proportion of patients who survived 5 years after surgery, taking into account any cause of death.	5 years
Perioperative complications	Complications occurring within 30 days after surgery. Perioperative complications are classified according to the Clavien-Dindo classification system and include intraoperative, short-term, and long-term postoperative complications. The following events are considered serious perioperative complications: hemorrhage requiring transfusion of >4 units of packed red blood cells; postoperative complications necessitating emergent surgical intervention; severe infection (as defined by the American College of Chest Physicians/Society of Critical Care Medicine 1992 criteria); and deaths attributable to the surgical procedure. These should be reported within 30 days postoperatively.	up to 30 days after surgery
Quality of the specimen	The data included specimen quality, positive margin rate, number of harvested lymph nodes and positive lymph nodes	up to 2 weeks after surgery
Incidence rates of polyps and adenomas	the incidence rates of polyps and adenomas as seen on colonoscopy at 1, 3 and 5 years after surgery respectively.	5 years
Scores of quality of life	measured by scores from the Gastrointestinal Symptom Rating Scale (GSRS) at 1, 2, and 3 years after surgery respectively, and scores from the EQ-5D-5L Quality of Life Scale at 1, 2, and 3 years after surgery respectively.	3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conversion Rate from Laparoscopic to Open Surgery	The proportion of laparoscopic surgeries that are converted to open surgeries due to intraoperative complications, technical challenges, or other clinical reasons.	Intraoperative period
LISH Surgery Completion Rate	The proportion of patients in whom the LISH procedure is successfully completed without conversion to TRH or other alternative surgical approaches.	Intraoperative period
Minimal Residual Disease (MRD) via Circulating Tumor DNA (ctDNA)	Detection of MRD using circulating tumor DNA (ctDNA) as a biomarker.	Preoperative (7 days), postoperative (7 days), and 3 months post-surgery
Short- and Long-Term Changes in Gut Microecology	Analysis of gut microbiota, epithelial cells, stromal cells, immune cells, and metabolic products using fecal samples and intestinal biopsy tissues.	Preoperative, postoperative 3 months, 6 months and 12 months
Glycemic Metabolic Indicators - Hemoglobin A1c (HbA1c)	Measurement of glycated hemoglobin (HbA1c) levels to assess long-term glycemic control.	Preoperative, 3 months, 6 months, and 12 months post-surgery
Oral Glucose Tolerance Test (OGTT)	Evaluation of glucose metabolism by measuring blood glucose and insulin levels at 0, 30, 60, 120 minutes after oral glucose administration.	Preoperative, 3 months, 6 months, and 12 months post-surgery
Insulin Resistance (HOMA-IR)	Calculation of insulin sensitivity using fasting glucose and insulin levels	Preoperative, 3 months, 6 months, and 12 months post-surgery

Collaborators and Investigators

• Sponsor: Zhejiang University
• Investigators: Principal Investigator: Kefeng Ding, PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2023
• Primary Completion (Estimated): May 14, 2026
• Study Completion (Estimated): May 14, 2031

Study Registration Dates

• First Submitted: May 30, 2023
• First Submitted That Met QC Criteria: June 19, 2023
• First Posted (Actual): June 28, 2023

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 25, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: laparoscopic right hemicolectomy; hepatic flexure colon cancer; proximal transverse colon cancer; ileocecus-sparing
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Colonic Neoplasms
• Other Study ID Numbers: CRCCZ-S03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No