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临床试验/NCT04348487
NCT04348487Unknown不适用

Modified Cephalica Venous Access Port Implantation

Udayana University2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2020年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
3
试验地点
2
主要终点
patency of chemoport

研究概览

简要总结

As long term totally implantable central venous access (TIVAPS) was increasingly needed in cancer patient, some modified techniques were introduced to improved the outcome and safety of the port implantation. In this modified technique, the prioritization were the safety and stability of catheter and port placement. Catheter was inserted to the cephalic vein in the deltopectoral groove, in which connected to the port pocket implanted in the anteromedial thorax. Connection was done by percutaenous and Seldinger technique by introducing a special trocar to ensure safety. Long term outcome was satisfactorily good by this technique without and major and minor events.

详细描述

Large studies have proved that TIVAPS was effective for long term venous access with minimal risk of complication. For TIVAPS, clinicians have approach the vena cava through the subclavian, internal jugular vein, or cephalic vein regularly with various technique. The most minimal complication risk was obtained in the access through cephalic vein.In the conventional method of cephalic central venous access approach, the incision was done at clavicular regio, with the high risk of catheter being kinking. To improve the feasibility of the techique, here, the author introduced the modified technique for cephalic vein approach.

Step 1 Preparation The patient was positioned supine with the head tilted to the left. In our procedure, the head was tilted to the left in order to expose the deltopetoral groove. The procedure was done in aseptic condition with iodine tincture and sterile draping. It was carried out under local anesthesia in an operating room. A two-gram of cephazolin was inserted intravenously following the guideline standard in the local hospital.

Step 2 Landmarks There were two landmark incision in this procedure, in which the first one is in deltopectoral groove for catheter insertion and the second is in anteromedial of thorax. The deltopectoral groove is located between the insertio of pectoralis major and deltoid muscle. The cephalic vein passes through the clavipectoral (deltopectoral) triangle to join the axillary vein. Lidocaine without adrenaline was used as a local anesthetic in both incision. The procedure was done without any radiology guidance.

Step 3 Vein identification The first incision was made for the insertion of venous catheter. As long as 2 to 3 cm incision was made in the deltopectoral groove. An incision of 3 mm in length was made on the surface of the vein. The incision was then deepened to the fascia overlying the deltoid and pectoralis muscle. Subcutaneous tissue was positioned by blunt dissection to uncover the cephalic vein. The cephalic vein was identified in the adipose tissue along the deltopectoral groove. Surgical cauterization was used to control bleeding. The proximal and distal end of the vein was secured by tying and a hemostat was applied for traction. A transverse venotomy was made at the center of these 2 sutures.

Step 4 Venous catheter insertion A peel-away sheath was inserted to facilitate the catheter insertion into the venous system. The catheter was inserted into the cephalic vein for approximately 25 centimeters.

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

性别
Female
接受健康志愿者

入选标准

  • Subjects who are planning to receive chemotherapy and need chemoports placement.

排除标准

  • Unconsented subjects

结局指标

主要结局

patency of chemoport

时间窗: 10 minutes after the insertion of chemoport

While flushing 10 ml of saline to chemoport, measure the velocity flow of saline injection. If the saline was complete in less than 1 minute, it was considered normal. difficulty in flushing the chemoport and pain during flushing should be considered as a failure.

location of chemoport

时间窗: 1 hour after the insertion of chemoport.

appropriate location of chemoport can be found by thorax X Ray, confirmed by radiographers evaluation.

次要结局

  • complication of chemoport(1 month after the insertion of chemoport)

研究者

发起方
Udayana University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Putu Anda Tusta Adiputra

Consultant, Division of Surgical Oncology, Department of Surgery, Udayana University

Udayana University

研究点 (2)

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