Investigate the Radical Extent of Lymphadenectomy of LAparoscopic Right Colectomy for Colon Cancer(RELARC).

Study Overview
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Brief Summary
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To investigate whether extended lymphadenectomy (CME) in laparoscopic colectomy could improve disease-free survival in patients with right colon cancer, compared with standard D2 radical operation.

Detailed Description
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Our study design is a two-arm, parallel-group, single-blind randomized clinical trial. The enrolled colon cancer patients would be divided into the intervention group (CME group) and control group (D2 radical operation group). The postoperative adjuvant chemotherapy is determined by the pathological results. For patients of stage Ⅲ and patients of stage Ⅱ with unfavorable histologic features, six months of adjuvant chemotherapy of XELOX or fluorouracil-based regimen are recommended. The postoperative examination should be performed every four months in the first two years and every six months in the following three years, to exclude local recurrence and distant metastasis. Our study is expected to last five years, of which two years for recruiting patients, three years for follow-up.

Official Title
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A Multicenter, Prospective, Randomized Clinical Trial to Investigate the Radical Extent of Lymphadenectomy: D2 Dissection vs. Complete Mesocolic Excision, of LAparoscopic Right Colectomy for Right-sided Colon Cancer.

Conditions
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Colon Cancer

Intervention / Treatment
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* Procedure: D2 radical operation
* Procedure: Complete mesocolic excision (CME)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients suitable for curative surgery 18-75years old ASA grade I-III Qualitative diagnosis: a pathological diagnosis of adenocarcinoma; Localization diagnosis: the tumor located between the cecum and the right 1/3 of transverse colon; Enhanced CT scan of chest, abdominal and pelvic cavity: assessment of tumor stage is T2-T4N0 or TanyN+; there is no distant metastasis. Informed consent Exclusion Criteria: Simultaneous or simultaneous multiple primary colorectal cancer; Preoperative imaging examination results show: (1) colon cancer of stage T1N0; (2) enlargement of lymph node at the root of mesocolon, in which case the D3 radical operation must be performed; Preoperative imaging examination results show: (1) Tumor involves the surrounding organs and combined organ resection need to be done; (2)distant metastasis; (3)unable to perform R0 resection; History of any other malignant tumor in recent 5 years, except for cervical carcinoma in situ which has been cured, basal cell carcinoma or squamous cell carcinoma of skin; Patients need emergency operation; Not suitable for laparoscopic surgery (i.e., extensive adhesion caused by abdominal surgery, not suitable for artificial pneumoperitoneum, etc). Informed consent refusal

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: D2 radical operation group<br>In D2 radical operation group(D2), the mesocolon should be removed and the dissection involves the paracolon and intermediate lymph nodes, which along the feeding vessels. | Procedure: D2 radical operation<br>* In D2 radical operation group(D2), the lymph node dissection is based on ligating the supplying vessels close to the right-side of superior mesenteric vein and clean up the surrounding lymph node and adipose tissue.<br>|
| Experimental: CME group<br>In complete mesocolic excision group (CME), in addition to D2 dissection, the whole mesocolon, from ascending colon to right half transverse colon, as well as the central lymph nodesmshould be entirely removed. | Procedure: Complete mesocolic excision (CME)<br>* In complete mesocolic excision group (CME), the dissecting extent includes the lymphatic and fat tissues surrounding the root of ascending mesocolon, which situated on the surface of superior mesenteric vein, and the root of right half of transverse mesocolon, which situated on the surface of pancreas neck.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival | The proportion of patients with no disease recurrence and metastasis after 3 years of surgery | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Complications occurring within 30 days after surgery | 30 days | 
| Postoperative mortality | Death occurred within 30 days after surgery | 30 days | 
| 3 years overall survival | The proportion of patients who survived 3 years after surgery | 3 years | 
| Metastasis rate of central lymph node (3rd station) | Metastasis rate of central lymph node (3rd station) | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Right colon cancer, Survival, Laparoscopic surgery