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临床试验/NCT04201002
NCT04201002已完成不适用

Squamous Cell Carcinoma Over Pilonidal Disease. A New Therapeutic Approach.

Hospital Provincial de Castellon1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1
试验地点
1
主要终点
Decrease in recurrence rate

研究概览

简要总结

Background: Pilonidal sinus is a very common disease. Malignant transformation occurs in 0,1% of patients. The investigators present a case of squamous cell carcinoma arised from recurrent pilonidal disease, managed by multimodal treatment.

Case presentation: The investigators present a 70-year-old man with chronic pilonidal sinus. Inflammation had worsened in previous months and exploration revealed a large ulcerative mass which biopsy showed a squamous cell carcinoma. CT scan and MRI imaging showed tumoral invasion of the coccyx and both gluteus major muscles. Neoadjuvant radiotherapy, chemotherapy as radiosensitizer and surgery with intraoperative radiotherapy was decided in the multidisciplinary tumor committee. Post neoadjuvant therapy MRI showed partial response with a decrease of the mass but persistence of the coccyx infiltration.

Surgery consisted in en-bloc resection of the tumor with presacral tissues, coccyx and partial gluteal resection. Intraoperative radiotherapy was administered over the sacrum and in the bed of the coccyx resection. One week later, reconstructive surgery was practiced using a latissimus dorsi free flap, advancement of gluteal flaps and skin graft. Histological examination showed no residual tumor. The patient is currently asymptomatic and he has a satisfactory quality of life.

Conclusions: Although squamous cell carcinoma is rare, it must be suspected in patients with recurrent pilonidal disease. Diagnosis is done by histological examination of biopsies. This type of tumors have a high local recurrence rate. The investigators propose a multimodal treatment that includes neoadjuvant radiotherapy and chemotherapy as radiosensitizer and surgery plus intraoperative radiotherapy with the aim to decrease local recurrence rate.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Squamous cell carcinoma over pilonidal disease

排除标准

  • Distant Metastases

结局指标

主要结局

Decrease in recurrence rate

时间窗: 1 year

Squamous cell carcinoma has a high recurrence rate, with surgery plus intraoperative radiotherapy we think it could decrease that recurrence rate.

次要结局

未报告次要终点

研究者

发起方
Hospital Provincial de Castellon
申办方类型
Other
责任方
Principal Investigator
主要研究者

Araceli Mayol Oltra

General Surgeon

Hospital Provincial de Castellon

研究点 (1)

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