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临床试验/NCT02455648
NCT02455648已完成不适用

Transplantation of Autologous Cell Sheets After Endoscopic Submucosal Dissection (ESD) for Early Adenocarcinoma of the Esophagus

Matthias Löhr1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2012年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
1
主要终点
Post-operative stenosis

研究概览

简要总结

Healing of mucosal defects after endoscopic mucosal resection in the oesophagus is prone to result in varying degrees of stenosis, especially if the resected area is large and/or circumferential. A new technique was described where autologous cells from the patients own oral mucosa are harvested and cultures on proprietary membranes (coated, temperature sensitive). These membranes, coined cell sheets, are used to cover the mucosal defects.

详细描述

Aim Our aim is to evaluate if mucosal wound healing after endoscopic resection of early cancers or pre-cancerous lesions in the esophagus can be enhanced by transplantation of autologous cell sheets, thus reducing the risk of esophageal stenosis.

Background Adenocarcinoma and Barrett's esophagus The incidence of esophageal adenocarcinoma (EAC) has increased rapidly in the western world during the last decades. The reason for this increase is unknown, however, there is a strong association between the risk of developing EAC and gastro esophageal reflux. Chronic reflux may lead to Barrett's esophagus (BE), a condition where the squamous epithelium of the esophagus is replaced by columnar epithelium(1). BE is a premalignant condition with a lifetime risk of progressing to EAC of 5% in men and 3% in women (2).

The rate of progression is dependent on the grade of dysplasia in BE. One meta-analysis showed that low-grade dysplasia had a cancer incidence of 17/1,000 patient-years while high-grade dysplasia had an incidence of 66/1,000 patient-years (3). Medical treatment can reduce reflux symptoms, but there is no proof that it can decrease the risk of progression.

Treatment High-grade dysplasia The American Gastroenterological Association guidelines recommend that patients with high-grade dysplasia should be treated with surgical resection, endoscopic therapy or be offered surveillance with endoscopy every 3 months (4).

The Japanese Society for Gastrointestinal Endoscopy (JGSE) has described that endoscopic mucosal resection (EMR) is suitable for BE with high-grade dysplasia given that the diameter is ≤2 cm, < 1/3 of the esophageal circumference and limited to the mucosa. One of several advantages with EMR is that the resected mucosa can be examined histologically, compared to ablative therapies. Briefly, EMR is performed by submucosal injection to separate esophageal wall layers and then resection of the mucosa with a snare. A similar technique is endoscopic submucosal dissection (ESD) which also includes a submucosal injection, but instead of using a snare for resecting, the lesion is dissected with cutting instruments, such as the insulation-tipped (IT) knife.

研究设计

研究类型
Interventional
分配方式
Randomized
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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Barrets esophagus, histologically confirmed, or early oesophageal cancer (both squamous and adeno)

排除标准

  • •no consent can be given
  • •prior ESD/EMR

研究组 & 干预措施

ESD/EMR plus Cell Sheet

Experimental

Patients receive both mucosal buccal biopsy and insertion of cell sheets during/after ESD/EMR

干预措施: ESD/EMR plus Cell Sheet (Procedure)

ESD/EMR

Sham Comparator

patients receive both mucosal biopsy but no placement of cell sheets during/after ESD

干预措施: ESD/EMR (Procedure)

结局指标

主要结局

Post-operative stenosis

时间窗: 4 weeks

Development of an oesophageal stenosis that cannot be passed by a standard 9 mm endoscope

次要结局

未报告次要终点

研究者

发起方
Matthias Löhr
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Matthias Löhr

Professor of Gastroenterology & Herpetology

Karolinska University Hospital

研究点 (1)

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