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临床试验/NCT02081547
NCT02081547Unknown不适用

IPC Status as a Surgical Quality Marker in Rectal Cancer Surgery

Uppsala University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
2
主要终点
IPC status

研究概览

简要总结

Risk of local recurrence after rectal surgery is nationally 8% after curative surgery to 5%. Local recurrence rate after curative surgery varies between 3-7% in the variety of regions in the country. It is well known that the surgical technique total mesorectal excision (TME) has led to improved prognosis after rectal cancer surgery. TME surgery is difficult to perform and different factors affect the quality of TME preparations. Injuries in mesorectal fascia has been reported in up to 20% of patients who underwent TME surgery and most surgeons agree that this may be important for recurrences. However, it is unclear to what extent a damaged mesorectal fascia can be related to a worsening of prognosis in patients with rectal cancer.

Adjuvant oncological treatment in form of chemotherapy after surgery, is offers patients with unfavorable tumors based on the pathological examination. Patients with favorable tumors (less advanced) are not offered chemotherapy, even if the surgical technique was not optimal, ie. that there is damage in the mesorectal fascia, as evidence for this is lacking.

The presence of intraperitoneal cancer cells (IPC) is related to histopathological tumor stage of colorectal cancer. Incidence of IPC of intraperitoneal tumors (rectal cancer patients with tumors below the peritoneal reflection) is unclear.

Assessment of IPC status with cytology and immunohistochemistry is technically easy and could after TME surgery identify those patients who have an increased risk of tumor recurrence. In a positive IPC status, the patient would possibly benefit from either postoperative radiotherapy if the patient did not receive preoperative therapy, or postoperative oncological chemotherapy.

Tumour cells may be lysed in sterile water, and some surgeons rinse the abdominal cavity and the bowel distally to the tumour. Neither rinsing the abdomen or rectum in colorectal cancer is routinely occurring and the clinical benefit has not been established. The value of rinsing the abdomen after TME-surgery could also be studied by IPC status.

The study hypothesis is that the IPC status is dependent on the surgical quality of the specimen after TME-surgery in rectal cancer patients, and its presence leads to increased risk of local recurrence.

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

  • •rectal cancer patients that are going to be operated with bowel resection
  • •control patients (10 patients) - patients with different conditions that are going to be operated.

排除标准

  • 未提供

结局指标

主要结局

IPC status

时间窗: One year

Occurence of cancer cells per 100 mesothelial cell for the sample taken at the start of the surgery (sample 1). After completion of the TME-Surgery (sample 2) and after rinsing the abdomen (sample 3). The outcome will be assessed and presented when all patients are included (approximately dec 2013).

次要结局

  • Survival(after 3-5 years)
  • TME quality(Day 1)
  • local recurrence(3-5 years after operation)

研究者

发起方
Uppsala University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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