CME Versus Standard Right Hemicolectomy for Right Sided Cancers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- we will assess the Number of harvested lymph nodes after colonic resectio
研究概览
简要总结
Our aim of this study is to compare the difference in lymph node yield in CME specimens versus those patients having a standard right hemicolectomy for right sided cancer .The secondary aim of this study was to investigate whether there is an interaction between greater lymph node harvest towards increased survival. Another subgroup analysis of this study is to compare the complications and oncological outcome between laparoscopic versus Robotic CME.
Trial Title CME versus standard right hemicolectomy for right sided cancers Internal ref. no. Clinical Phase Trial Design Observational, prospective, international, multi-center study Trial sites 10 sites over 5 different countries Planned Sample Size At least 330 subjects will be enrolled in this study per cohort, including 10% of lost to follow-up patients).
All patients during the enrolment period shall be screened and recorded at sites in order to identify any selection bias Treatment duration 3 years Follow up duration 5 years Planned Trial Period 10 years Objectives Outcome Measures Primary To compare the lymph node yield between complete mesocolic excision versus standard right hemicolectomy for patients with right sided cancer Number of harvested lymph nodes Secondary Incidence of local recurrence after surgery at 2 and 5 years
Disease free survival (2 and 5 years)
5-year overall survival
30-day and 90-day mortality,
60-day postoperative major complications (As measured by the Comprehensive Complication Index (CCI®).)
Pathological quality assessment. Completeness of mesocolon excision (CME) will be assessed by the pathologist
Operative length of time (total OR utilisation time and operative time skin to skin, minutes)
Assessment of intraoperative adverse events within advanced minimally-invasive surgery in order to report "near misses" and associated impact upon clinical outcomes
Conversion to open surgery
For Minimally invasive CME or standard right hemicolectomy - to compare the types of anastomosis (intra-corporeal versus Extra-coporeal ) on anastomosis leak rate 4. 5. 6. 7. Recurrence picked up on intensive follow up schedules with yearly CT scan for 5 years
Definitions:
Distal resected margin ≥ 5cm Lymph node yield Mesocolic plane of surgery Central vascular ligation (within 1cm of ileocolic vessels origins) R0 resection (all margins clear)
Investigational Medicinal Product(s) n/a Formulation, Dose, Route of Administration n/a
详细描述
CRC is the third most common cancer in men and second most common in women with almost 55% of these cases occurring in more developed nations Findings from a recent population-based study showed that the oncological outcome was worse for right-sided colon cancers than left-sided colon cancers. The authors also noted that the overall survival after curative surgery for right-sided colon cancer was better in patients whose surgery led to a lymph node yield of 22 or more. Other studies also confirmed these findings of better outcome after more extensive lymph node dissection for colon cancer.
To achieve this strategy of increased lymph node yield, a complete mesocolic excision (CME) of the colonic cancer have been proposed. This concept of CME aims to extrapolate the teaching of total mesorectal excision for rectal cancer to colonic cancer by separating the mesocolic from the parietal plane and true central ('high') ligation of the supplying arteries and draining veins. All the lymph nodes along the tumour supplying vessels are contained in the specimen Hohenberger et al have used this technique in 1329 consecutive cases and have found decreased5-year local recurrences rates of colon cancers (from 6.5% to 3.6%) and increased cancer-related 5-year survival rates (82.1% to 89.1%).
However the CME technique remains controversial as the evidence of increased disease-free survival after CME is mainly based on only two single centre studies Complete mesocolic excision is also a more challenging operation than a standard right hemicolectomy. This is due to the complex vascular anatomy of the right colon, and hence many surgeons and surgical units have refrained from performing right-sided complete mesocolic excision.
Nevertheless a few international centres have started to implement CME surgery for right-sided cancers. In Japan for example, central lymph node dissection similar to complete mesocolic excision is recommended for clinical stage T3-4 or pN1-2 tumours. Berthelsen et al recently published their results of central mesocolic lymph node excision on risk of recurrence after resection for right-sided colon adenocarcinoma. They implemented CME as the standard surgical approach for colon cancer in their hospital since 2008.The authors noted that CME has the potential to reduce the risk of recurrence and improve long-term outcome after resection for all UICC stages I-III of right-sided colon adenocarcinomas.
AIM OF THE STUDY Our aim of this study is to compare the difference in lymph node yield in CME specimens versus those patients having a standard right hemicolectomy for right sided cancer .The secondary aim of this study was to investigate whether there is an interaction between greater lymph node harvest towards increased survival. Another subgroup analysis of this study is to compare the complications and oncological outcome between laparoscopic versus Robotic CME.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is willing and able to give informed consent for participation in the trial.
- •Male or Female, aged 18 years or above.
- •Undergoing CME or standard right hemicolectomy surgery for right-sided cancer after MDT discussion.
- •Cancer must be confirmed by histological, radiological, endoscopic diagnosis
- •In the Investigator's opinion, is able and willing to comply with all trial requirements.
排除标准
- •Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
- •Participant with life expectancy of less than 6 months.
- •Distal Transverse colon and splenic flexure tumors
- •Evidence of T4 disease invading adjacent organs
- •Synchronous surgical procedure planned with CME or right hemicolectomy
- •Urgent, unplanned or emergency surgery
- •Neoadjuvant chemotherapy administered to treat this cancer prior to resection
- •Concurrent or previous abdominal or pelvic malignancy within five years prior to registration irrespective of treatment modality
- •Known Crohn's disease with active terminal ileal disease
- •Evidence of systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude surgery, or other severe incapacitating disease, i.e. ASA IV (a patient with severe systemic disease that is a constant threat to life) or ASA V (a moribund patient who is not expected to survive without the operation).
- •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
结局指标
主要结局
we will assess the Number of harvested lymph nodes after colonic resectio
时间窗: 3 years anticipated
The primary aim of the study is to compare the lymph node yield between CME and standard right hemicolectomy in right sided cancers
次要结局
- Incidence of local recurrence after surgery at 1,3 and 5 years(5 years)
- Pathological quality assessment(90 days)
- Overall survival at 5 and 10 years(10 years)
- Assessment of intraoperative adverse events of the surgery(90 days)
- Health related quality of life(1,3 and 5 years)
- mortality and morbidity(90 days)
- Health economics assessements(24 months)
研究者
Issam al-Najami
principal investigator
Odense University Hospital