LISH Trial for the Hepatic Flexure and Proximal Transverse Colon Cancer

January 25, 2026 updated by: Ding Ke-Feng, Zhejiang University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
568

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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:
        • Principal Investigator:
          • Ke-Feng Ding, phD/MD
        • Contact:
      • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
3-year disease free survival
Time Frame: 3 years
the time from enrollment until disease relapse or death from any cause 3 years after surgery
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Scores from the EQ-5D-5L Quality of Life Scale
Time Frame: 3 years
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)
Time Frame: 5 years
The proportion of patients who survived 5 years after surgery, taking into account any cause of death.
5 years
Perioperative complications
Time Frame: up to 30 days after surgery
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
Time Frame: up to 2 weeks after surgery
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
Time Frame: 5 years
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
Time Frame: 3 years
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Conversion Rate from Laparoscopic to Open Surgery
Time Frame: Intraoperative period
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
Time Frame: Intraoperative period
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)
Time Frame: Preoperative (7 days), postoperative (7 days), and 3 months post-surgery
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
Time Frame: Preoperative, postoperative 3 months, 6 months and 12 months
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)
Time Frame: Preoperative, 3 months, 6 months, and 12 months post-surgery
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)
Time Frame: Preoperative, 3 months, 6 months, and 12 months post-surgery
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)
Time Frame: Preoperative, 3 months, 6 months, and 12 months post-surgery
Calculation of insulin sensitivity using fasting glucose and insulin levels
Preoperative, 3 months, 6 months, and 12 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhejiang University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kefeng Ding, PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 14, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 14, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 14, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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