Feasibility and Therapeutic Potential of Free Fat Grafts in the Treatment of Esophageal Strictures
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 主要终点
- Incidence of Treatment-Emergent Adverse Events at 12 months
研究概览
简要总结
In this study the investigators investigate the feasibility and therapeutic potential of free autologous fat grafting combined to dilation therapy in the treatment of benign esophageal strictures.
详细描述
In this study the investigators wish to proof the concept of free fat graft transfer into esophageal stricture via flexible video gastroscope.The investigators will recruit twenty patients suffering from (endoscopy proven) benign stricture of the esophagus. The Eckardt score is recorded upon recruitment and one day before operation.
The operation is performed at the gastroenterology outpatient clinic in Turku University Hospital by a gastrointestinal surgeon. The patient is sedated with alfentanil and midazolam. First, abdominal liposuction (roughly 20 ml) is performed under local infiltration anesthesia. The fat graft is processed into nano-fat using Tulip GEMS Single-Use NanoTransfer Set. Esophagoscopy with gastroscope is performed and stricture is visually graded (location, length, lumen) and photographed. Then esophageal stricture is biopsied with biopsy forceps and dilated with through-the-scope CRE(controlled radial expansion) balloon dilator. Prepared fat graft is injected beneath the mucosal layer at the stricture site (volume of 0,1-0,5 ml) at three locations. Patients are either discharged after two hours follow up or admitted to the inpatient ward, depending on the pre- and postoperative condition.
Patients are contacted by phone 1 week after the operation. Post-operative symptoms are recorded and patients are requested to contact the researcher if needed. Patient records are screened for pre- and postoperative symptoms, medication, long term illnesses and possible postoperative contacts to hospital.
Follow-up esophagoscopy is performed and biopsies taken three and 12 months after the first operation. The stricture site is visually graded and photographed. The Eckardt score is recorded. If the patient has problems with eating (Eckardt score dysphagia points more than 1) the stricture is re-dilated and fat grafting repeated.
If a patient would have recurrence in dysphagia before three months the patient is treated according to normal routine and dilation is repeated earlier.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Esophageal stricture that has re-occurred at least once
排除标准
- •Malignant etiology of esophageal stricture
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events at 12 months
时间窗: 12 months
Types, severity and probability of procedure related adverse events
Incidence of Treatment-Emergent Adverse Events at 3 months
时间窗: 3 months
Types, severity and probability of procedure related adverse events
次要结局
- Change from Baseline Stricture length at 12 months(12 months)
- Change from Baseline Eckardt-score at 12 months(12 months)
- Change from Baseline Stricture Lumen diameter at 3 months(3 months)
- Change from Baseline Stricture Lumen diameter at 12 months(12 months)
- Change from Baseline Eckardt score at 3 months(3 months)
- Change from Baseline Stricture length at 3 months(3 months)
研究者
Hannes Kortekangas
Gastrointestinal surgeon / Consultant in Division of Gastrointestinal Surgery
Turku University Hospital