Management of Malignant Colorectal Polyps (T1) After Endoscopic Polypectomy: Follow-up vs Surgery and Analysis of Pathological Risk Factors for Lymph Nodes Metastasis. A Retrospective and Prospective Multicentric Observational Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 615
- 试验地点
- 1
- 主要终点
- Number of patients with lymph nodes metastasis in pT1 colorectal cancer
研究概览
简要总结
Colorectal cancer screening showed an increased incidence of malignant colorectal polyps pT1 after endoscopic excision. Their management is not yet standardized, for the presence of histological features increasing early lymph node involvement. The literature has proposed several histopathological criteria, for which the risk of lymph node metastasis can vary (6-20%), but final data are not yet available.
Aim 1.To collect data about patients undergoing an endoscopic polypectomy with histologic finding of pT1, retrospectively and prospectively, dividing both databases into two groups, endoscopic group (EG) and surgical group (SG) Aim 2. To analyze retrospectively which pathological criteria can increase the risk of lymph node metastasis and to elaborate a prognostic score for lymph node metastatic risk Aim 3. To verify prospectively the prognostic score capacity on predicting lymph node metastasis Aim 4. To calculate the disease free survival, overall survival, local recurrence rate and distal recurrence rate and verify if there is a difference between EG and SG
According to literature, the most important histopathological criteria to establish the high risk of lymph node metastasis are:
- Lateral margin of healthy tissue (high risk: <1mm and piecemeal polypectomy)
- Depth of submucosa invasion (high risk: >1000 μM or sm2-sm3 for sessile polyps; Haggitt level 4 for pedunculated polyps)
- Vascular invasion (high risk: presence)
- Lymphatic invasion (high risk: presence)
- Tumor budding (high risk: presence)
- Tumor differentiation (high risk: grade G3-G4 or mucinous)
A database will be used by all participating centres for collecting clinical and pathological data. All the analyses will be centralized by the PI. Uni-multivariate analyses will be conducted at the end of data collection for retrospective arm and at 2 years of follow-up for prospective arm.
Impact: This study aimed to investigate pathological risk factors for lymph node metastasis in pT1 colorectal polyps after endoscopic polypectomy; their accurate identification could lead to improve their management, avoiding useless complementary surgery. Results could change clinical practice and reduce health-related costs.
详细描述
The management of malignant colorectal tumors pT1 after polypectomy is not yet standardized, for the presence of histological features increasing early lymph node involvement. Three recent meta-analysis have identified some pathological criteria influencing the risk of lymph node metastasis in early colorectal cancer, but there is not agreement in the conclusions between these articles. Because this uncertainty, the decision making criteria for this patients can be different in every Institute. Furthermore, the majority of the literature refers to surgical patients, with lack in demonstrating, at long-term, the absence of lymph nodes metastasis in patients not operated after endoscopic polypectomy.
Retrospective study:
From a retrospective period of 6 years, with at list 2 years of follow-up, all patients who underwent endoscopic polypectomy for malignant colorectal polyp pT1, will be enrolled for the study.
The patients will be divided into two groups: patients who did only the endoscopic treatment (EG), and patients who underwent complementary surgery (SG).
The most important histopathological criteria to list in the database, when available (to establish the high risk of lymph node metastasis) are as follows:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •All patients who underwent an endoscopic colorectal polypectomy for malignant polyp pT1
排除标准
- •Age < 18 years
- •Gastrointestinal cancer previously diagnosticated or synchronous
结局指标
主要结局
Number of patients with lymph nodes metastasis in pT1 colorectal cancer
时间窗: Enrollment
The six pathological criteria will be tested as independent predictors of lymph node metastasis
Disease free survival in EG and SG and in patients with and without high risk factors
时间窗: 24 months
次要结局
- Overall survival(24 months)
- Developing a clinical prognostic score for lymph node metastasis(Enrollment)
- Validating the clinical prognostic score as predictor of lymph node metastasis(Enrollment)
- Local and distal recurrence rate in EG and SG and in high risk patients and low risk patients(24 months)
- Sensitivity and specificity of diagnostic tests in detecting pathologic lymph nodes(Enrollment)
研究者
Dario Parini
Principal Investigator
Azienda Ospedaliera di Perugia