Colon Cancer
Conditions
Keywords
Right colon cancer, Survival, Laparoscopic surgery
Brief summary
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
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.
Interventions
PROCEDURED2 radical operation
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.
PROCEDUREComplete mesocolic excision (CME)
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.
Sponsors
Chinese PLA General Hospital
Sixth Affiliated Hospital, Sun Yat-sen University
Peking University Cancer Hospital & Institute
Beijing Friendship Hospital
Xuanwu Hospital, Beijing
Ruijin Hospital
Shanghai Zhongshan Hospital
The First Hospital of Jilin University
Nanfang Hospital, Southern Medical University
Fujian Medical University Union Hospital
Peking Union Medical College
Peking University People's Hospital
The First Affiliated Hospital with Nanjing Medical University
First Affiliated Hospital of Harbin Medical University
RenJi Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
West China Hospital
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival | 3 years | The proportion of patients with no disease recurrence and metastasis after 3 years of surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications | 30 days | Complications occurring within 30 days after surgery |
| Postoperative mortality | 30 days | Death occurred within 30 days after surgery |
| 3 years overall survival | 3 years | The proportion of patients who survived 3 years after surgery |
| Metastasis rate of central lymph node (3rd station) | 7 days | Metastasis rate of central lymph node (3rd station) |
Countries
China
Outcome results
None listed