Hepatic Flexure Colon Cancer, Proximal Transverse Colon Cancer
Conditions
Keywords
hepatic flexure colon cancer, proximal transverse colon cancer, ileocecus-sparing, laparoscopic right hemicolectomy
Brief 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.
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).
Interventions
PROCEDURELISH （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.
PROCEDURETRH（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.
Sponsors
Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year disease free survival | 3 years | the time from enrollment until disease relapse or death from any cause 3 years after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative complications | 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. |
| Quality of the specimen | up to 2 weeks after surgery | The data included specimen quality, positive margin rate, number of harvested lymph nodes and positive lymph nodes |
| Incidence rates of polyps and adenomas | 5 years | the incidence rates of polyps and adenomas as seen on colonoscopy at 1, 3 and 5 years after surgery respectively. |
| Scores of quality of life | 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. |
| Scores from the EQ-5D-5L Quality of Life Scale | 3 years | scores from the EQ-5D-5L Quality of Life Scale at 1, 2, and 3 years after surgery respectively. |
| 5-year overall survival rate (OS) | 5 years | The proportion of patients who survived 5 years after surgery, taking into account any cause of death. |
Countries
China
Contacts
CONTACTKefeng Ding, PhD
PRINCIPAL_INVESTIGATORKefeng Ding, PhD
Second Affiliated Hospital, School of Medicine, Zhejiang University
Outcome results
None listed