Investigate the Radical Extent of Lymphadenectomy of LAparoscopic Right Colectomy for Colon Cancer(RELARC).
- Conditions
- Colon Cancer
- Interventions
- Procedure: Complete mesocolic excision (CME)Procedure: D2 radical operation
- Registration Number
- NCT02619942
- Lead Sponsor
- Peking Union Medical College Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1072
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CME group Complete mesocolic excision (CME) 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. D2 radical operation group D2 radical operation 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.
- Primary Outcome Measures
Name Time Method Disease-free survival 3 years The proportion of patients with no disease recurrence and metastasis after 3 years of surgery
- Secondary Outcome Measures
Name Time Method 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)
Postoperative complications 30 days Complications occurring within 30 days after surgery
Postoperative mortality 30 days Death occurred within 30 days after surgery
Trial Locations
- Locations (1)
Lai XU
🇨🇳Beijing, Beijing, China