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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LISH (Laparoscopic Ileocecal-Sparing Right Hemicolectomy) | Procedure | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kefeng Ding, PhD | Contact | 86-571-87784720 | dingkefeng@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Kefeng Ding, PhD | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Bengbu Medical Collage | Recruiting | Bengbu | Anhui | China |
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| TRH(Traditional Laparoscopic Right Hemicolectomy) | Procedure | 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. |
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| 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 |
| 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 |
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 |
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
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| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
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| Cancer Hospital Academy of medicine Scenice | Recruiting | Beijing | Beijing Municipality | China |
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| the First Affiliated Hospital of Chongqing Medical Collage | Recruiting | Chongqing | Chongqing Municipality | China |
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| Fujian Cancer Hospital | Recruiting | Fuzhou | Fujian | 350001 | China |
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| Fujian Hospital Medical Union University | Recruiting | Fuzhou | Fujian | 350001 | China |
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| The First Affiliated Hospital of Xiamen University | Not yet recruiting | Xiamen | Fujian | China |
| Guangdong Second Provincial General Hospital | Recruiting | Guangzhou | Guangdong | 510317 | China |
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| The Sixth Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510655 | China |
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| Union Hospital, Tongji Medical College, Huazhong University of Science and Technolog | Recruiting | Wuhan | Hubei | China |
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| People's Hospital of Hunan Province | Recruiting | Changsha | Hunan | China |
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| Jiangsu province hospital | Not yet recruiting | Nanjing | Jiangsu | China |
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| Nanjing Drum Tower Hospital | Recruiting | Nanjing | Jiangsu | China |
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| The Second Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | China |
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| Shandong Cancer Hospital | Recruiting | Jinan | Shandong | 250117 | China |
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| The Affiliated Hospital of Qingdao University | Recruiting | Qingdao | Shandong | 266003 | China |
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| Changhai Hospital of Shanghai | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
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| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | China |
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| Ruijin Hospital Affiliated of The Shanghai Jiao Tong University Medical School | Recruiting | Shanghai | Shanghai Municipality | China |
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| The first affiliated hospital of xi'an jiaotong university | Recruiting | Xi’an | Shanxi | 710000 | China |
| West China Hospital of Sichuang University | Recruiting | Chengdu | Sichuan | China |
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| The Cancer Hospital Affiliated of The Xingjiang University Medical School | Recruiting | Xinjiang | Xinjiang | China |
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| Yunnan Cancer Hospital | Recruiting | Kunming | Yunnan | China |
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| Second Affiliated Hospital Zhejiang University College of Medicine | Recruiting | Hangzhou | Zhejiang | 310999 | China |
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| Sir Run Run Shaw Hospital, Zhejiang University School of medicien | Recruiting | Hangzhou | Zhejiang | China |
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| Zhejiang Cancer Hospital | Not yet recruiting | Hangzhou | Zhejiang | China |
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| Jinhua Municipal Central Hospital | Recruiting | Jinhua | Zhejiang | China |
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| Ningbo No.2 Hospital | Recruiting | Ningbo | Zhejiang | China |
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