Metastasis, Overall Survival, Postoperative Complications, Stage, Colon Cancer
Conditions
Keywords
CME, Right hemi Colon cancer, D3, laparoscopy
Brief summary
To standardize the surgery for advanced right hemi colon cancer with laparoscopy and investigate whether extended lymphadenectomy (CME) could improve disease-free survival in patients with right colon cancer, compared with D3 radical operation in laparoscopic colectomy.
Interventions
PROCEDURECME
the group underwent laparoscopic right hemicolectomy with CME. In CME group, in addition to D2 dissection, the whole mesocolon, from ascending colon to right half transverse colon, as well as the central lymph nodes should be entirely removed. Intervention: Procedure: Complete mesocolic excision (CME)
PROCEDURED3
the group underwent laparoscopic right hemicolectomy with D3 lymph node dissection. In D3 group, the mesocolon should be removed and the dissection involves the paracolon and intermediate lymph nodes,including No.6 lymph node, which along the feeding vessels. Intervention: Procedure: D3 radical operation
Sponsors
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
RenJi Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Fudan University
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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. Qualitative diagnosis: a pathological diagnosis of adenocarcinoma; 3. Localization diagnosis: the tumor located between the cecum and the right 1/3 of transverse colon; 4. Enhanced CT scan of chest, abdominal and pelvic cavity: assessment of tumor stage is T stage 1-4 and N stage 0-2; there is no distant metastasis. 5. Informed consent
Exclusion criteria
1. Simultaneous or simultaneous multiple primary colorectal cancer; 2. 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; 3. History of any other malignant tumor in recent 5 years; 4. Patients need emergency operation; 5. Not suitable for laparoscopic surgery; 6. Women during Pregnancy or breast feeding period; 7. Informed consent refusal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| The rate of postoperative complications and mortality | 30 days |
| 3 years overall survival | 3 years |
| The rate of local and distant recurrence | 3 years |
| The accuracy of preoperative staging with CT | 14 days |
Contacts
Primary ContactMinhua Zheng, PhD
Backup ContactHiju Hong, PhD Student
Outcome results
None listed