Hepatic Flexure Colon CancerNCT05923255
LISH Trial for the Hepatic Flexure and Proximal Transverse Colon Cancer
A study testing LISH （Laparoscopic Ileocecal-Sparing Right Hemicolectomy） and TRH（Traditional Laparoscopic Right Hemicolectomy） in people with Hepatic Flexure Colon Cancer and Proximal Transverse Colon Cancer, run by Zhejiang University at 29 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatic Flexure Colon Cancer, Proximal Transverse Colon Cancer
- What is being tested?
- LISH （Laparoscopic Ileocecal-Sparing Right Hemicolectomy） and TRH（Traditional Laparoscopic Right Hemicolectomy）
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 568 participants
- Where
- 29 sitesChina
- Study dates
- 14 May 2023to 14 May 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18-75 years old
- ASA classification ≤III
- Colon adenocarcinoma confirmed by endoscopy and pathological biopsy
- 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)
- Preoperative clinical staging: TanyNanyM0
- Patients able to understand the study protocol, willing to participate in the research, and providing written informed consent
Who cannot join
- Preoperative examination indicates synchronous multiple primary colorectal cancers or other diseases requiring bowel segment resection
- 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
- Additional radical surgery following Endoscopic Mucosal Resection (EMR) and Endoscopic Submucosal Dissection (ESD) procedures
- 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
- Presence of bowel obstruction, bowel perforation, or intestinal bleeding requiring emergency surgery
- Patients unsuitable for or unable to tolerate laparoscopic surgery
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- Pregnant or lactating women
- Patients with a history of psychiatric disorders
- Patients who have received neoadjuvant therapy prior to surgery
- Patients deemed unsuitable for the study by MDT discussion
- Patients unable to understand the study's conditions and objectives, and refusing to sign informed consent.
Trial locations and contacts
29 sites in 1 country. Contact the study team or a site near you to ask about taking part.
29 sites in 1 country
China29 sites, 29 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100000
Aiwen Wu, PhD
Xiangqian Su, PhD
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100000
Yi Xiao, PhD
Yi Xiao, PhD
- Recruiting
Cancer Hospital Academy of medicine Scenice
Beijing, Beijing Municipality
Qian Liu, phD
Xishan Wang
- Recruiting
the First Affiliated Hospital of Bengbu Medical Collage
Bengbu, Anhui
Muling Liu, phD
Muling Liu, phD
- Recruiting
People's Hospital of Hunan Province
Changsha, Hunan
Zhigang Xiao, phD
Zhongcheng Huang, phD
- Recruiting
West China Hospital of Sichuang University
Chengdu, Sichuan
Ziqiang Wang, phD
Ziqiang Wang, phD
- Recruiting
the First Affiliated Hospital of Chongqing Medical Collage
Chongqing, Chongqing Municipality
Zhengqiang Wei, phD
Zhengqiang Wei, phD
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350001
Chunkang Yang, PhD
Chunkang Yang, MD
- Recruiting
Fujian Hospital Medical Union University
Fuzhou, Fujian, 350001
Pan Chi
Pan Chi, M.D.
- Recruiting
Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, 510317
Han Fanghai, Prof.
- Recruiting
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655
Wu Xiaojian
- Recruiting
Second Affiliated Hospital Zhejiang University College of Medicine
Hangzhou, Zhejiang, 310999
Ke-Feng Ding, phD/MD, 86-571-87784827, dingkefeng@zju.edu.cn
Jian Wang, phD/MD, 0571-87784720, wangjian519@zju.edu.cn
- Recruiting
Sir Run Run Shaw Hospital, Zhejiang University School of medicien
Hangzhou, Zhejiang
Xuefeng Huang, phD
Xuefeng Huang, phD
- Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Haixing Ju, phD
Haixing Ju, phD
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
Sun Yanlai, Prof.
- Recruiting
Jinhua Municipal Central Hospital
Jinhua, Zhejiang
Jinlin Du, phD
Jinlin Du, phD
- Recruiting
Yunnan Cancer Hospital
Kunming, Yunnan
Yunfeng Li, phD
Yunfeng Li, phD
- Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Shengxun Mao, phD
Shengxun Mao, phD
- Not yet recruiting
Jiangsu province hospital
Nanjing, Jiangsu
Yueming Sun, phD
Yueming Sun, phD
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu
Gang Chen, phD
Gang Chen, phD
- Recruiting
Ningbo No.2 Hospital
Ningbo, Zhejiang
Xiaoyu Dai, phD
Xiaoyu Dai, phD
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003
Zhou Yanbin, Prof.
- Recruiting
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality, 200433
Wei Zhang
Wei Zhang, MD
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Ye Xu, phD
Xinxiang Li, phD
- Recruiting
Ruijin Hospital Affiliated of The Shanghai Jiao Tong University Medical School
Shanghai, Shanghai Municipality
Bo Feng, phD
Bo Feng, phD
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technolog
Wuhan, Hubei
Kaixiong Tao, phD
Kaixiong Tao, phD
- Recruiting
The first affiliated hospital of xi'an jiaotong university
Xi’an, Shanxi, 710000
- Not yet recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian
- Recruiting
The Cancer Hospital Affiliated of The Xingjiang University Medical School
Xinjiang, Xinjiang
Haijiang Wang, phD
Haijiang Wang, phD
About this study
Official title: 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.
Read the 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).
- Being tested
- LISH （Laparoscopic Ileocecal-Sparing Right Hemicolectomy）, TRH（Traditional Laparoscopic Right Hemicolectomy）
- Keywords
- hepatic flexure colon cancer, proximal transverse colon cancer, ileocecus-sparing, laparoscopic right hemicolectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LISH （Laparoscopic Ileocecal-Sparing Right Hemicolectomy）Procedure or surgery
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）Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| LISH （Laparoscopic Ileocecal-Sparing Right Hemicolectomy）group | Experimental | 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. Receives: Procedure: LISH （Laparoscopic Ileocecal-Sparing Right Hemicolectomy） |
| TRH （Traditional Right Hemicolectomy）group | Active comparator | In TRH group, patients suffering from cancer of the hepatic flexure and proximal transverse colon will be undergoing the traditional radical right hemicolectomy. Receives: Procedure: TRH（Traditional Laparoscopic Right Hemicolectomy） |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease free survival
the time from enrollment until disease relapse or death from any cause 3 years after surgery
Measured: 3 years
Secondary outcomes (6)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 3 years
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.
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start14 May 2023
- Primary completion14 May 2026 (estimated)
- Study completion14 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic Flexure Colon CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 568 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ding Ke-Feng, Zhejiang University
- Investigators
- Kefeng Ding, PhD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05923255
- Sponsor's protocol ID
- CRCCZ-S03
- Status last verified
- Jan 2026
- First submitted
- 30 May 2023
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Ileocecal-Sparing Right Hemicolectomy for Cancer of the Hepatic Flexure and Proximal Transverse Colon -- A Prospective, Multicenter Randomized Control Clinical Trial
- ClinicalTrials.gov ID
- NCT05923255
- Acronym / sponsor ID
- CRCCZ-S03
- Keywords
- hepatic flexure colon cancer, proximal transverse colon cancer, ileocecus-sparing, laparoscopic right hemicolectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 568 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 14 May 2023 (actual)
- Primary completion
- 14 May 2026 (estimated)
- Study completion
- 14 May 2031 (estimated)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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: 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LISH （Laparoscopic Ileocecal-Sparing Right Hemicolectomy）group | Experimental | Procedure: LISH （Laparoscopic Ileocecal-Sparing Right Hemicolectomy）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. |
| TRH （Traditional Right Hemicolectomy）group | Active comparator | Procedure: TRH（Traditional Laparoscopic Right Hemicolectomy）In TRH group, patients suffering from cancer of the hepatic flexure and proximal transverse colon will be undergoing the traditional radical right hemicolectomy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18-75 years old
- ASA classification ≤III
- Colon adenocarcinoma confirmed by endoscopy and pathological biopsy
- 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)
- Preoperative clinical staging: TanyNanyM0
Key exclusion criteria (11 listed)
- Preoperative examination indicates synchronous multiple primary colorectal cancers or other diseases requiring bowel segment resection
- 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
- Additional radical surgery following Endoscopic Mucosal Resection (EMR) and Endoscopic Submucosal Dissection (ESD) procedures
- 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
- Presence of bowel obstruction, bowel perforation, or intestinal bleeding requiring emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | LISH （Laparoscopic Ileocecal-Sparing Right Hemicolectomy）group |
| 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. | Procedure or surgery | TRH （Traditional Right Hemicolectomy）group |
Primary outcome
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
6 secondary outcomes
Perioperative complications
Time frame: up to 30 days after surgery
Quality of the specimen
Time frame: up to 2 weeks after surgery
Incidence rates of polyps and adenomas
Time frame: 5 years
Scores of quality of life
Time frame: 3 years
Scores from the EQ-5D-5L Quality of Life Scale
Time frame: 3 years
5-year overall survival rate (OS)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kefeng Ding, PhD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LISH （Laparoscopic Ileocecal-Sparing Right Hemicolectomy） and TRH（Traditional Laparoscopic Right Hemicolectomy） in people with Hepatic Flexure Colon Cancer and Proximal Transverse Colon Cancer, run by Zhejiang University at 29 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kefeng Ding, PhD (86-571-87784720, dingkefeng@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.