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临床试验/NCT05069766
NCT05069766已完成不适用

Preoperative Marking of the Oral Resection Margin in Esophageal Cancer With a Surgical Fiducial Marker - First Experiences

Rigshospitalet, Denmark2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Registration of visibility of BioXmark™

研究概览

简要总结

This study aims to evaluate if BioXmark™, a surgical marker, may efficiently and safely be used to preoperatively mark the proximal and distal resection line 5 cm proximal and distal to the tumor margin of gastroesophageal-junction adenocarcinoma (GEJ AC).

Furthermore, to determine if placing the resection margin according to the resection margin defined by BioXmark™ is superior to the current standard of a proximal resection line estimation by the individual surgeon based on the intraoperative findings.

详细描述

In Denmark, the national guidelines for GEJ AC surgery are an R0 resection with a minimum 5 cm proximal and distal resection margin, measured in vivo. During the operation, the primary surgeon sets the resection margin according to the guidelines, with 5 cm on either side.

The Danish national guidelines are clear, but the literature behind them is not, and the recommendations for resection margins vary worldwide. With the lack of a strong literature-backed guideline and a surgical approach that is heavily dependent on the individual surgeon's estimate, the risk of a microscopic positive resection margin (R1 resection) increases. Both problems, namely resectability at the definitive surgery and the incidence of microscopic positive resection margins after resection, may be improved by preoperatively marking the tumor margins in vivo. This could be achieved with an endoscopically placed surgical marker.

One such surgical marker is BioXmark™, a liquid injectable and adherent fiducial marker that has shown promising results for image-guided adaptive radiotherapy in lung, bladder, and esophageal cancer. BioXmark™ is implanted during endoscopy and has appropriate visibility with good positional stability on CT, CBCT, and MRI. Furthermore, no adverse reactions or events have been reported yet.

The study will be performed as a feasibility study of BioXmark™ at the Department of Surgery & Transplantation, Centre of Cancer and Organ Diseases. The investigators plan to include 10 patients who are scheduled to undergo curatively intended surgery for GEJ AC. The patients will be drawn from the existing operating program.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients referred with gastroesophageal adenocarcinoma to the Department of Surgery & Transplantation, Centre of Cancer and Organ Diseases, Rigshospitalet, and who are candidates for curatively intended surgery.

排除标准

  • Patients under the age of
  • Patients diagnosed with disseminated disease during surgery.
  • Patients with impaired cognitive ability, making obtainment of informed consent impossible

结局指标

主要结局

Registration of visibility of BioXmark™

时间窗: From day 0 to the day of operation

BioXmark™ feasibility in terms of visibility with ultrasound during surgery CT-scans after neoadjuvant and visibility and positional stability during CT-scanning following neoadjuvant chemotherapy preoperatively.

Registration of treatment related side effects assessed by CTCAE V 5.0

时间窗: Day 0 to 2 weeks after implantation

This is part of a safety evaluation and will be registered by CTCAE into Adverse Events (AE) and Serious Adverse Events (SAE)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Trygve Ulvund Solstad

Research Scholar

Rigshospitalet, Denmark

研究点 (2)

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