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Power PortBPIPNCT02887261

Study on Indications of "Bard" PowerPort Isp Implantable Port

A study testing "Bard"PowerPort sip Implantable Port and Conventional Port in people with Power Port and Image Accuracy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 90 years
Conditions the study is for
Power Port, Image Accuracy
What is being tested?
"Bard"PowerPort sip Implantable Port and Conventional Port
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteTaiwan
Study dates
May 2016to 31 May 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with esophageal cancer that in the clinical stage of T3~4 N0~2 M0 before treatment and presents no distant metastasis

Who cannot join

  • Patients with esophageal cancer that in the clinical stage of TxN3M1 before treatment and presents no distant metastasis

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Chang Gung Memorial Hospital

    Taoyuan, 333

Other trials in Taiwan

About this study

Official title: Study on Indications of "Bard" PowerPort Isp Implantable Port: Image Accuracy in Resectable Esophageal Cancer Patients

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.

Read the 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.

Being tested
"Bard"PowerPort sip Implantable Port, Conventional Port
Keywords
Power Port

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • "Bard"PowerPort sip Implantable PortDevice

    capable for power injection for contrast media.

  • Conventional PortDevice

    not for power injection for contrast media.

Study groups in NCT02887261
Study groupRoleWhat they receive
Power PortOtherpatients who received power injectable port
Receives: Device: "Bard"PowerPort sip Implantable Port
Conventional PortActive comparatorpatients who received conventional port ( not power injectable)
Receives: Device: Conventional Port

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Chest tomography (Before and after neoadjuvant therapy)

    tumor invasion status ( CT result)

    Measured: 1. before neoadjuvant CCRT ( just after diagnosis) 2. after neoadjuvant CCRT prior surgery intervention(for treatment response after neoadjuvant CCRT; 3~4 months after neoadjuvant CCRT.)

  2. endoscopic ultrasound (Before and after neoadjuvant therapy)

    tumor invasion status ( EBUS image result)

    Measured: 1. before neoadjuvant CCRT ( just after diagnosis) 2. after neoadjuvant CCRT prior surgery intervention(for treatment response after neoadjuvant CCRT; 3~4 months after neoadjuvant CCRT.)

  3. pathologic report

    Real tumor invasion status

    Measured: After curative surgery ( 3-4 months after treatment completion)

Secondary outcomes (1)
  1. Chest tomography (Before and after neoadjuvant therapy)

    Tumor size shrinkage

    Measured: 1. before neoadjuvant CCRT ( just after diagnosis) 2. after neoadjuvant CCRT prior surgery intervention( 3-4 months after neoadjuvant CCRT)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2016 (estimated)
  2. Study startMay 2016
  3. Primary completion31 May 2019
  4. Study completion31 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02887261
Sponsor's protocol ID
CGMH-IRB-104-3143A3
Acronym
BPIP
Status last verified
Dec 2018
First submitted
29 Jun 2016
Last updated
24 Jul 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Publications

  • Charvat J, Linke Z, Horaekova M, Prausova J. Implantation of central venous ports with catheter insertion via the right internal jugular vein in oncology patients: single center experience. Support Care Cancer. 2006 Nov;14(11):1162-5. doi: 10.1007/s00520-006-0073-2. Epub 2006 Apr 5.

    PubMed 16596418
  • Copper CM, Pacanowski JP, Bell JL. The trapezius port: a novel approach for port access. Am Surg. 2005 Feb;71(2):106-9.

    PubMed 16022007
  • Broviac JW, Cole JJ, Scribner BH. A silicone rubber atrial catheter for prolonged parenteral alimentation. Surg Gynecol Obstet. 1973 Apr;136(4):602-6. No abstract available.

    PubMed 4632149
  • Hickman RO, Buckner CD, Clift RA, Sanders JE, Stewart P, Thomas ED. A modified right atrial catheter for access to the venous system in marrow transplant recipients. Surg Gynecol Obstet. 1979 Jun;148(6):871-5. No abstract available.

    PubMed 109934
  • Niederhuber JE, Ensminger W, Gyves JW, Liepman M, Doan K, Cozzi E. Totally implanted venous and arterial access system to replace external catheters in cancer treatment. Surgery. 1982 Oct;92(4):706-12.

    PubMed 7123491
  • Belzunegui T, Louis CJ, Torrededia L, Oteiza J. Extravasation of radiographic contrast material and compartment syndrome in the hand: a case report. Scand J Trauma Resusc Emerg Med. 2011 Feb 4;19:9. doi: 10.1186/1757-7241-19-9.

    PubMed 21294896
  • Azais H, Bresson L, Bassil A, Katdare N, Merlot B, Houpeau JL, El Bedoui S, Meurant JP, Tresch E, Narducci F. Chemotherapy drug extravasation in totally implantable venous access port systems: how effective is early surgical lavage? J Vasc Access. 2015 Jan-Feb;16(1):31-7. doi: 10.5301/jva.5000316. Epub 2014 Oct 16.

    PubMed 25362986
  • Petterson TM, Marks RS, Ashrani AA, Bailey KR, Heit JA. Risk of site-specific cancer in incident venous thromboembolism: a population-based study. Thromb Res. 2015 Mar;135(3):472-8. doi: 10.1016/j.thromres.2014.12.013. Epub 2014 Dec 16.

    PubMed 25547213
  • Lyman GH, Bohlke K, Khorana AA, Kuderer NM, Lee AY, Arcelus JI, Balaban EP, Clarke JM, Flowers CR, Francis CW, Gates LE, Kakkar AK, Key NS, Levine MN, Liebman HA, Tempero MA, Wong SL, Somerfield MR, Falanga A; American Society of Clinical Oncology. Venous thromboembolism prophylaxis and treatment in patients with cancer: american society of clinical oncology clinical practice guideline update 2014. J Clin Oncol. 2015 Feb 20;33(6):654-6. doi: 10.1200/JCO.2014.59.7351. Epub 2015 Jan 20.

    PubMed 25605844
  • Baptista R, Santiago I, Jorge E, Teixeira R, Mendes P, Curvo-Semedo L, Castro G, Monteiro P, Caseiro-Alves F, Providencia LA. One-shot diagnostic and prognostic assessment in intermediate- to high-risk acute pulmonary embolism: the role of multidetector computed tomography. Rev Port Cardiol. 2013 Jan;32(1):7-13. doi: 10.1016/j.repc.2012.05.020. Epub 2012 Dec 11.

    PubMed 23245344
  • Rice TW. Clinical staging of esophageal carcinoma. CT, EUS, and PET. Chest Surg Clin N Am. 2000 Aug;10(3):471-85.

    PubMed 10967751
  • Sandha GS, Severin D, Postema E, McEwan A, Stewart K. Is positron emission tomography useful in locoregional staging of esophageal cancer? Results of a multidisciplinary initiative comparing CT, positron emission tomography, and EUS. Gastrointest Endosc. 2008 Mar;67(3):402-9. doi: 10.1016/j.gie.2007.09.006.

    PubMed 18178202
  • Sloof GW. Response monitoring of neoadjuvant therapy using CT, EUS, and FDG-PET. Best Pract Res Clin Gastroenterol. 2006;20(5):941-57. doi: 10.1016/j.bpg.2006.04.004.

    PubMed 16997171
  • Yegin EG, Duman DG. Staging of esophageal and gastric cancer in 2014. Minerva Med. 2014 Oct;105(5):391-411. Epub 2014 Jul 7.

    PubMed 25000218
  • Isenberg G, Chak A, Canto MI, Levitan N, Clayman J, Pollack BJ, Sivak MV Jr. Endoscopic ultrasound in restaging of esophageal cancer after neoadjuvant chemoradiation. Gastrointest Endosc. 1998 Aug;48(2):158-63. doi: 10.1016/s0016-5107(98)70157-9.

    PubMed 9717781

Questions about this trial

What is this clinical trial studying?

A study testing "Bard"PowerPort sip Implantable Port and Conventional Port in people with Power Port and Image Accuracy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chest tomography (Before and after neoadjuvant therapy) (time frame: 1. before neoadjuvant CCRT ( just after diagnosis) 2. after neoadjuvant CCRT prior surgery intervention(for treatment response after neoadjuvant CCRT; 3~4 months after neoadjuvant CCRT.)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02887261, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.

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