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

N/AUnknownNCT02619942

Peking Union Medical College Hospital1,072 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

1,072

Conditions

Colon Cancer

Interventions

D2 radical operationPROCEDURE

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.

Complete mesocolic excision (CME)PROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients suitable for curative surgery 18-75years old 2. ASA grade I-III 3. Qualitative diagnosis: a pathological diagnosis of adenocarcinoma; 4. Localization diagnosis: the tumor located between the cecum and the right 1/3 of transverse colon; 5. Enhanced CT scan of chest, abdominal and pelvic cavity: assessment of tumor stage is T2-T4N0 or TanyN+; there is no distant metastasis. 6. Informed consent Exclusion Criteria: 1. Simultaneous or simultaneous multiple primary colorectal cancer; 2. 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; 3. 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; 4. 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; 5. Patients need emergency operation; 6. Not suitable for laparoscopic surgery (i.e., extensive adhesion caused by abdominal surgery, not suitable for artificial pneumoperitoneum, etc). 7. Informed consent refusal

Locations (1)

Lai XU

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Disease-free survival

The proportion of patients with no disease recurrence and metastasis after 3 years of surgery

Time frame: 3 years

Secondary Outcomes

Postoperative complications

Complications occurring within 30 days after surgery

Time frame: 30 days

Postoperative mortality

Death occurred within 30 days after surgery

Time frame: 30 days

3 years overall survival

The proportion of patients who survived 3 years after surgery

Time frame: 3 years

Metastasis rate of central lymph node (3rd station)

Time frame: 7 days

Data from ClinicalTrials.gov

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