Local Excision for Organ Preservation in Early REctal Cancer With No Adjuvant Treatment (LORENA Trial).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Success rate
研究概览
简要总结
Rectal cancer is one of the most frequent malignant tumors nowadays. There are several possible treatment options including chemotherapy, radiotherapy and surgery. Surgery for early stage rectal cancer can be either a radical surgery (RS) or a local excision (LE).
A radical surgery removes the rectum including the tumor and the lymph nodes through which it spreads, improving survival but with a possible impact in the patients quality of life (QoL). A local excision only removes the tumor and a safety margin of healthy rectum. This has the potential to avoid the possible complications and QoL decrease. However there are some complications after a LE and also poor prognostic factors inherent to the tumor biology that can lead the surgical team to perform a RS after LE with worse outcomes. These are impossible to know before the procedure.
The goal of this registry is to determine the frequency of these poor prognostic biological factors and complications in patients undergoing LE for early rectal cancer.
The main question it aims to answer are:
• How frequently does LE allow for rectum preservation?
Participants will undergo LE for early rectal cancer when it is considered the best treatment by their surgeons according to their expertise and protocols. Patients will follow the standard treatment that would be given to them, and the biological prognostic factors and the appearance of complications will be recorded.
详细描述
Registry´s main hypothesis:
Exclusive LE is insufficient for in situ rectum preservation in cT1N0M0 extraperitoneal rectal adenocarcinoma in ≥20% of the patients treated with this approach in real everyday´s clinical practice.
A database will be design recording demographics, tumor details, type of intervention, complications, histological details and further necessity of treatments and rectal preservation along time. It will be hosted online through the REDCap system.
Data entry will be done baseline, after surgical procedure, and at different follow-up periods, at 30 postoperative day and at 6, 12, 18, 24 and 36 months after surgical intervention.
Sample size calculation:
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
- •Patients age 18 years or older.
- •Histologic proof of infiltrating rectal adenocarcinoma. or
- •Preoperative biopsy compatible with rectal adenoma or intramucous adenocarcinoma with endoscopic or radiological suspicion of infiltrating adenocarcinoma.
- •Endoscopic criteria: Kudo´s crypt pattern of V or higher, despite non confirmatory preoperative histology. endoscópicos: patrón de criptas V o superior según la clasificación de Kudo, que define lesiones infiltrantes, a pesar de que la histología preoperatoria no sea confirmatoria .
- •Ultrasonographic criteria: hipoecogenic rectal tumor invading the intermediate hyperecogenic layer (submucosal), but does not infiltrate the hypoecogenic outer layer (muscularis propia).
- •Radiological criterio in MR: tumor invades the submucosal layer without infiltration of the rectal muscularis propia. The usual low signal submucosal image is substituted with an aberrant signal, meaning the loss of the zebra pattern in a normal rectal wall.
- •Rectal neoplasm with an inferior limit no further than 2cm proximal to the anorectal verge, both in digital rectal examination and in radiology examinations, ideally magnetic resonance (MR).
- •Rectal neoplasms up to 3 cm of major diameter.
- •Clinical preoperative staging of cT1N0M0, based on endoscopy, MR, +/- endorectal ultrasound.
- •Cases in which LE as exclusive treatment with curative intent is prescribed after MDT discusión, regardless of the approach both via flexible endoscopy and transanal endoscopic microsurgery and its variations.
- •Neoplasms with low risk histologic criteria known preoperatively or lack of information regarding this aspect:
- •Submucosal infiltration of less than 1000µm (sm1 in the Kikuchi classification) .
- •Tumor budding absent.
- •En bloc resection in patients with a previous endoscopic resection.
- •Vascular, lymphatic and perineural invasión absent.
- •Low histologic grade.
排除标准
- •Patients younger than 18 years old.
- •Rectal neoplasms different from adenocarcinoma.
- •Neoplasms in which the inferior edge is farther than 2cm proximal to the anorectal verge in the preoperative MR.
- •Any other clinical stage other than cT1N0M0 (any T>1, N+, or M+).
- •Neoplasms larger than 3cm.
- •Preoperatively demonstration of PPHF:
- •Submucosal infiltration deeper than 1000µm (sm2 and sm3 in the Kikuchi classification)
- •Tumor budding present.
- •Piecemeal resection in cases with previous endoscopic resection.
- •Vascular, lymphatic and perineural invasión presence.
- •High histologic grade.
- •Any patient with planned systemic treatment with RTQT combined with the LE after MDT discusión, regardless of the preoperative clinical or postoperative pathological stage.
结局指标
主要结局
Success rate
时间窗: 36 months
Rate of patients with no need of Total Mesorectal Excision after follow-up
次要结局
- Morbidity rate(2 months)
- Histological poor outcome predictor rate(1 month)
- Radicality of resection(1 month)
- Radical rescue surgery specimen quality(1 month)