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临床试验/NCT04107623
NCT04107623已完成不适用

Quantitative Fluorescent Guided Robotic Surgery for Cancer of the Gastroesophageal Junction

Rigshospitalet, Denmark2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020年6月16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
70
试验地点
2
主要终点
perfusion assessment

研究概览

简要总结

The investigators also aim to use our previously described quantifying method (q-ICG), to evaluate changes in gastric perfusion, during resection of cancer in the gastroesophageal junction (GEJ) and if a change in the operative technique influences microvascular flow in the gastroesophageal (GE) anastomosis.

详细描述

  1. Introduction

2.1 Adenocarcinoma of the gastroesophageal tract Adenocarcinoma of the gastroesophageal tract, including the esophagus, stomach, and gastroesophageal junction (GEJ) is a growing clinical challenge worldwide due to the increasing incidence and poor prognosis. Current management of resectable GEJ cancer involves comprehensive diagnostic procedures followed by standardized treatment with surgery and pre- and postoperative chemotherapy.

At our department, 90 patients are annually treated for resectable cancer of the GEJ. The surgery comprises of an Ivor Lewis procedure with either open or robot-assisted mobilization of the stomach with limited (D1+) lymphadenectomy and creation of the gastric conduit and pyloroplasty (2). Here, the creation of the gastric conduit involves partial preservation of the right gastric artery. The right gastric artery is ligated approximately half way up the lesser curvature, and the remaining conduit stapled (figure 1). Theoretically, the preservation of both the gastro-epiploic and right gastric artery should result in improved vascular patency and blood supply to the anastomosis. The theoretical advantages of preserving the right gastric artery may have some oncological drawbacks as placing the line of resection half way up the lesser curvature allows for a limited lymph node (LN) dissection, leaving behind some tissue comprising of LN station number 3b and 5 (figure 1). Lymph node metastasis is a significant prognostic factor in gastroesophageal cancer, and the American Joint Committee on Cancer recommends an extensive lymphadenectomy to achieve accurate N staging.

In contrast, the creation of a gastric tube by serial applications of a linear-cutting stapling device parallel to the greater curvature (ligating the right gastric artery) could generate a larger LN harvest, but this could be at the expense of anastomotic and conduit perfusion. A retrospective series noted an increase in gastric tip necrosis and neck leaks with intrathoracic extension when a narrower gastric tube (3 to 4 cm) was used. Contrary, several randomized trials, and cohort studies have been conducted regarding the size of the gastric tube with no differences in anastomotic leakage rates being reported. However, the consensus is that a gastric tube of five cm width in both open and minimal invasive oesophagostomy is the optimal size. No difference in the rates of anastomotic leakage, anastomotic stenosis, or delayed gastric emptying has been seen between ligating or preserving the right gastric artery. Thus, both ligating and preserving the right gastric artery are considered viable surgical options.

Figure 1. A) Schematic image of the gastric blood vessels. B) Resection when ligating the right gastric artery, C) Resektion when preserving the right gastric artery. D) Schematic image and partial lymphatic overview, circled are lymph node stations 3b. and 5. resected in "B" and left behind in "C".

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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 (above 18 years) scheduled for planned open or robot-assisted resection of gastroesophageal junction cancer.

排除标准

  • Allergy towards; iodine, indocyanine green or shellfish
  • Severe liver insufficiency
  • Thyrotoxicosis
  • Nephropathy requiring dialysis
  • Pregnancy or lactation
  • Legally incompetent for any reason
  • Withdrawal of inclusion consent at any time

结局指标

主要结局

perfusion assessment

时间窗: The perfussion assesment takes 3-5min.

The primary endpoint is the difference in conduit- and anastomotic perfusion between the two groups. The perfusion will be measured intraoperativly using q-ICG.

次要结局

  • Anastomotic leakage(the patients will be follow 30 days after surgery)
  • Lymph node resektion(Caculated after the return of pathology report. The patients will be followed 30 days after surgery)
  • short term surgical outcome(Patients will be follow for 30 days after surgery)

研究者

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

JENS OSTERKAMP

PhD fellow, MD

Rigshospitalet, Denmark

研究点 (2)

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