LISH Trial for the Hepatic Flexure and Proximal Transverse Colon Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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: (1)90-day postoperative complications; (2)Pathology-related indicators, including positive margin rate, number of harvested lymph nodes and lymph node metastasis rate;(3) 5-year overall survival rate (OS)

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

Conditions
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Hepatic Flexure Colon Cancer, Proximal Transverse Colon Cancer

Intervention / Treatment
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* Procedure: LISH （Laparoscopic Ileocecal-Sparing Right Hemicolectomy）
* Procedure: TRH（Traditional Laparoscopic Right Hemicolectomy）


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LISH （Laparoscopic Ileocecal-Sparing Right Hemicolectomy）group<br>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）<br>* 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.<br>|
| Active Comparator: TRH （Traditional Right Hemicolectomy）group<br>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）<br>* 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.<br>|

What is the study measuring?
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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 |
| --- | --- | --- |
| Postoperative complications | Complications occurring within 30 days after surgery, classified according to the Clavien-Dindo system, including intraoperative, short-term, and long-term postoperative complications.Index (CCI) will be recorded | up to 30 days after surgery | 
| Metastasis rate of harvested lymph nodes | according to the pathological report | up to 2 weeks after surgery | 
| Quality of CME (complete mesocolic excision) | After the specimen had been harvested, photographs of the anterior and posterior aspects of the specimens were uploaded to the electronic data capture system. On the basis of the anterior and posterior photographs, the specimens were classified into three groups of the quality of CME: grade I, intact mesocolon; grade II laceration in the mesocolon; and grade III laceration in the mesocolon reaching the bowel. | up to 2 weeks after surgery | 
| Length of resected specimen | On the basis of the anterior and posterior photographs, the length of resected specimen were measured. | up to 2 weeks after surgery | 
| Resection margins distance | On the basis of the anterior and posterior photographs, the distal and proximal resection margins distance of the resected intestinal specimen were measured. | up to 2 weeks after surgery | 
| Vascular pedicle length of resected specimen | On the basis of the anterior and posterior photographs, the vascular pedicle length of the resected intestinal specimen were measured. | up to 2 weeks after surgery | 
| Positive margin rate | positive margin rate of resected specimen according to the pathological report | up to 2 weeks after surgery | 
| Incidence rates of polyps | the incidence rates of polyps as seen on colonoscopy at 1, 3 and 5 years after surgery respectively. | 5 years | 
| Incidence rates of adenomas | the incidence rates of adenomas as seen on colonoscopy at 1, 3 and 5 years after surgery respectively. | 5 years | 
| Scores from the Gastrointestinal Symptom Rating Scale (GSRS) | scores from the Gastrointestinal Symptom Rating Scale (GSRS) 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatic flexure colon cancer, proximal transverse colon cancer, ileocecus-sparing, laparoscopic right hemicolectomy