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临床试验/NCT02090816
NCT02090816已完成不适用

Combined Liver and Right Lung Resection for Colorectal Metastases by Means of J-shaped Thoracophrenolaparotomy

University of Milan1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2004年9月最近更新:
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
1
主要终点
Number of metastases removed

研究概览

简要总结

The purpose of this study is to determine whether J-shaped thoracophrenolaparotomy is effective in the surgical treatment of simultaneous liver and right lung metastases from colorectal cancer

详细描述

Right-sided lung metastases are resected synchronously with liver metastases by means of a thoracophrenolaparotomy.

The pre-operative staging includes for all patients colonoscopy, thoracic and abdominal contrast enhanced computed tomography (CT), contrast enhanced magnetic resonance (MRI) of the upper abdomen, and 18-fluorodeoxyglucose PET scan.

Laboratory examinations including liver function tests, spirometry, cardiologic and anesthesiological evaluation are also performed in alla patients.

Surgical Procedures The patient is placed in supine position with the arms extended laterally. The anaesthesiologist for selective lung insufflation positions the double lumen endotracheal tube. The J-shaped abdominal incision conventionally adopted for liver surgery is performed. In case of tumors involving segment 1 or cranial segment portion of segments 4 superior, 7 and 8 close to the caval confluence, the incision is prolonged along the 9th right intercostal space allowing the access to thoracic cavity. The incision of the skin and the external oblique muscle reaches the anterior axillary line. A small portion, about 2 centimetres, of the cartilaginous costal arch is removed, and then the diaphragm is divided in a radial direction. The inner parietal incision, involving parietal pleura and intercostal muscles is prolonged up to the posterior axillary line preserving the intercostal neurovascular bundle.

Intraoperative ultrasound (IOUS) is performed in all patients to stage the liver involvement as well as to assess the relation between tumors and vascular structures and guidance in the dissection of hepatic parenchyma. If nodules are isoechoic in comparison to the surrounding tissue, the staging is completed with contrast-enhanced IOUS (CEIOUS); the contrast agent consists of 4.8 mL of microbubbles filled with sulfur hexafluoride (SonoVue®; Bracco Imaging, Italy), which is injected intravenously.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Controlled primary disease;
  • No extrahepatic lesion other than resectable pulmonary metastases at preoperative investigation;
  • No lymph-node metastases except for those eventually present at the hepatic hilum;
  • Disregarding number and distribution of liver metastases, technical resectability leaving at least a remnant liver volume of at least 40% of the total liver volume (calculated excluding the tumoral volume) featured by preserved inflow, outflow and biliary drainage. Zero mm free margin was considered acceptable in case of contact or close adjacency (< 5 mm) with 1st or 2nd order portal pedicles and/or major hepatic veins at their caval confluence;
  • Disregarding number and distribution of lung metastases, all of the detected nodules could be completely removed preserving enough functioning remnant lung based on the results of the preoperative cardio-pulmonary functional tests;
  • Patients eligible for a J-shaped thoracophrenolaparotomy because carrier of liver metastases located at the caval confluence, or in the paracaval portion of segment 1 or in the upper right segments (4 superior, 7 and 8), or presenting strong-adhesion or infiltration of the diaphragm.

排除标准

  • Patients not suitable for surgery

结局指标

主要结局

Number of metastases removed

时间窗: Baseline: date of surgical operation

Evaluation of the resectability of whole metastases in liver and right lung in the same operation by means of the same surgical incision (J-shaped thoracophrenolaparotomy)

次要结局

  • Number of patients that received interventional treatments after surgery(Participants will be followed from the baseline (date of surgery) to 90 days after the operation)
  • Number of re-operated patients(Participants will be followed from the baseline (date of surgery) to 90 days after the operation)

研究者

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

Prof. Guido Torzilli

Professor of Surgery

University of Milan

研究点 (1)

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