Study on Indications of "Bard" PowerPort Isp Implantable Port
Condition: Power Port; Image Accuracy
Study type: Interventional

Summary: 
      For esophageal cancer patients,chest CT could provide more accurate staging information and
      eliminated operation that could not achieve R0 resection such as T4 disease. However, the
      variation image quality was usual encountered because of contrast medium was injected via
      peripheral vein. Power injectable port could provide a secure vascular access as
      administration route for contrast medium via central vein. This could provide higher
      intravascular contrast medium concentration and could lead better image quality. This study
      divided into two arms, one group planned to receive power injectable port and another
      received conventional port. The aim of study was tried to identified the image differences
      between different contrast medium administration route and the its survival impact of
      esophageal cancer.
    

Detailed description: 
      It is extremely important for cancer patients to have a reliable vascular access which may be
      used for administering irritant infusions, such as chemotherapeutic agents and intravenous
      nutrition supplement, and for drawing blood for routine examinations in the long term. To
      address patients' needs, Aubaniac introduced the central vein puncture technique for vascular
      infusion in 1952AD. With this technique, patients were allowed to take intravenous infusion
      safely but had to experience repeated punctures every 5-7 days for preventing tunnel tract
      infection. Later, with the improvement of medical material, the first indwelling intravenous
      catheter was designed by BrovIac which could be implanted for a period of time. In 1979,
      based on this prototype, Hickmen added a subcutaneous cuff in order to separate the proximal
      part of catheter from environment and minimize the risk of tunnel tract infusion, leading to
      cosmetic concerns and compromising patients' daily activities . It's till 1982 that Dr.
      Niederhuber developed the totally implantable venous device, which made vascular access set
      up simpler for patients. However, low injection pressure setting constrained some
      applications, such as power injection of contrast media for CT scan. Therefore, peripheral
      venous puncture was still inevitable sometimes for the patients with intravenous access
      devices placed.

      Patients with cancer need to regularly receive imaging surveillance to evaluate treatment
      efficacy. Besides, the surveillance imaging provides benchmark reference for adjustment of
      treatment plan. To provide the enhanced quality of image, contrast media is expected to be
      administered at certain injection rates. Such requested injection rates would generate high
      pressures due to the sticky nature of the contrast media. Most of the time, the pressures
      incurred are far beyond the pressure setting of the conventional ports which mostly in the
      range of 10 ~ 12 atmospheric pressures (approximately 145 ~ 175 psi) and may cause device
      rupture or burst. Venipuncture is still unavoidable for oncologic patients with intravenous
      port implanted for administering contrast media so that patients' vessels cannot be
      completely protected from repeated venipunctures. Besides, patients' native vessel has its
      own infusion pressure limitation. Extravasation of contrast media to peripheral soft tissues
      would happen to the patients with poor vessels or to those in need for power injection of
      contrast media. Extravasation of contrast media may lead to cutaneous necrosis at different
      degrees. Such a consequence not only causes pain to patients, but also postpones the
      subsequent treatment that cannot be continued until the wound is healed up. The delay of
      treatment might impact on patients' survival. To avoid such a complication, radiologists are
      forced to lower the infusion velocity of contrast media and compromise the quality of the
      image requested by the diagnosis.

      Tumor would induce neovascularization process which may trigger abnormal new vessels to form
      and surround the lesion for providing the requested nutritional support for its growth. Given
      by this characteristic, the contrast-enhanced image plays an important role in evaluating the
      degree of tumor invasion. In addition, information regarding relative anatomic relationship
      between tumor and surrounding vital structure is also crucial for formulation of a treatment
      plan. However, as medical image is not color but black and white images, images with sharp
      contrast can present subtle changes of tumor more clearly as reference for evaluation of
      physicians. If the resectability and the metastatic lesions could be identified from medical
      images as early as possible, personalized treatment could be planned to achieve better
      survival rates. Therefore, it is extremely important to acquire a clear medical image. With
      respect to conventional CT, it can indicate the relative anatomical relationship between
      tumor and surrounding vital structures, which is a key basis for formulation of treatment
      plan. Current initial imaging data shows CT images taken after infusion with an implanted
      port that can endure a high infusion pressure are actually different from those taken after
      infusion through peripheral vein Theoretically, contrast media administrated via central vein
      could increase concentration of contrast media within a short time, improving the imaging
      quality of tissues close to the tumor greatly and reducing the necessity of peripheral
      venipuncture and the risk of contrast extravasation. Therefore, an implantable port that can
      endure a high infusion pressure is the only solution to meet the demand both from treatment
      and from surveillance. Furthermore, venous thrombus is more likely to occur in patients with
      malignant tumor, which must be prevented as it may cause a higher in-hospital mortality rate.
      If loosen thrombus delivered by venous return may lead most serious complications, such as
      pulmonary embolism. Pulmonary artery angiography was used to be the only way for diagnosis.
      However, with the improvement of imaging technology, computed tomography now could be
      utilized in diagnosis too. High quality of image may be achieved as long as contrast media is
      injected at a high velocity but patients might risk getting hurt by extravasation of contrast
      media. After intravenous port that could endure high injection pressure was available, the
      characteristic of high volume profile could provide secure vascular route with minimal risk
      of extravasation. However, there was no agreeable conclusion on how such a device may benefit
      the survival of the patients. Although the port that can endure a high pressure of infusion
      can provide a reliable intravenous route and better medical images, the benefits of prognosis
      which may be brought by such port are still unknown. Besides, the national insurance hasn't
      reimbursed such new type of infusion port due to limited insurance budget. Therefore,
      investigators intend to identify the patients suitable for implantation of such port in view
      of features of imaging and tumor so as to improve prognosis of cancer patients.
    

Intervention name(s): "Bard"PowerPort sip Implantable Port; Conventional Port
Intervention type(s): Device; Device
Intervention description(s): capable for power injection for contrast media.; not for power injection for contrast media.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Power Port