abstrak complications due to the use of totally implantable venous

ABSTRAK
COMPLICATIONS DUE TO THE USE OF TOTALLY IMPLANTABLE
VENOUS ACCESS PORT FOR CHEMOTHERAPY IN BREAST CANCER
PATIENTS IN RSUP SANGLAH BY 2015
LATAR BELAKANG : Angka kejadian kanker payudara pada wanita hamper
setiap tahunnya mengalami peningkatan. Pilihan terapi yang tepat dan sesuai sangat
diperlukan untuk mencapai kondisi terbaik bagi tiap pasien. Salah satu metode terapi
yang paling sering digunakan untuk mengobati kanker adalah melalui kemoterapi.
Metode pemberian obat-obatan kemoterapi juga harus diperhatikan untuk
meningkatkan kualitas hidup pasien. Bagaimanapun juga, tiap metode pemberian
kemoterapi memiliki resiko komplikasinya masing-masing. Penelitian ini dilakukan
untuk mengetahui komplikasi yang terjadi pada pasien wanita dengan kanker
payudara yang menjalani kemoterapi menggunakan TIVAP di RSUP Sanglah periode
Maret 2015 – September 2016.
METODE : Penelitian ini menggunakan metode deskriptif dengan desain
potong lintang menggunakan data sekunder dari bagian rekam medis RSUP Sanglah.
di Bali. Data rekam medis yang diperlukan diambil dari sampel pasien kanker
payudara dengan kriteria wanita yang terdaftar menjalani kemoterapi dengan TIVAP
di RSUP Sanglah.
HASIL : Dari 28 sampel yang diperiksa, didapatkan riwayat komplikasi
penggunaan TIVAP sebanyak 3 orang. Selanjutnya hasil penelitian menunjukkan
bahwa dari 28 sampel : (1) Rerata usia di atas 40 tahun; (2) Sembilan belas sampel
merupakan pasien kanker payudara sebelah kiri (3) Tujuh belas sampel memilih
menggunakan TIVAP berdasarkan keinginan pribadi setelah lebih dahulu diberikan
KIE oleh dokter;(4) Rerata usia kemoport (TIVAP) adalah 324 hari, dan pada 20
sampel dilakukan pemasangan port di vena subklavia; (5) Tiga sampel mengalami
komplikasi kemoport dengan rincian sebagai berikut : satu sampel mengalami
komplikasi awal blocking , dan dua sampel mengalami komplikasi lanjut berupa
exposed chemoport dan infeksi.
KESIMPULAN : Hasil keseluruhan kejadian komplikasi pada pasien kanker
payudara yang melakukan pemasangan TIVAP di RSUP Sanglah pada bulan Maret
2015 – September 2016 adalah 9%, dan tergolong aman dan baik untuk
diimplementasikan bagi pasien yang mendapatkan kemoterapi sebagai pengobatan
kanker payudara.
Kata kunci: kanker payudara, kemoterapi, TIVAP , wanita, komplikasi dari TIVAP.
i ABSTRACT
COMPLICATIONS DUE TO THE USE OF TOTALLY IMPLANTABLE
VENOUS ACCESS PORT FOR CHEMOTHERAPY IN BREAST CANCER
PATIENTS IN RSUP SANGLAH BY 2015
BACKGROUND : The incidence of breast cancers in women is increasing
every year. To achieve the best condition possible for patients the choice of treatment
is very important. One of the main therapy for patients with malignant tumor is
through chemotherapy. The method of chemotherapy might play important role in
giving a better quality of life to patients, however there is always a possibility of
complication to every procedure. This research is done to understand the
complication that happened in women with breast cancers who undergo
chemotherapy using TIVAP in RSUP Sanglah from March 2015 to September 2016.
METHOD : This research uses descriptive method with cross sectional design
using secondary data from the Medical Record installation in RSUP Sanglah. The
data were collected from breast cancer patients who are registered in RSUP Sanglah
with the criteria of being women who underwent chemotherapy procedure using
TIVAP from March 2015 to September 2016.
RESULT : Of 28 samples collected, the complications of TIVAP occurred in
3 samples. Furthermore, the results show that of the 28 samples: (1) The average age
of samples were above 40 years old; (2) Nineteen samples were diagnosed with left
breast cancers (3) Seventeen samples chose TIVAP based on personal preference for
chemotherapy access after education was given; (4) The average days of insertion
were 324 days, and the TIVAP access in twenty patients were placed in subclavian
vein; (5) Three patients suffered from complications with one patient suffered from
early complication of blocking, and two patients suffered from late complications of
exposed chemotherapy and infection respectively.
CONCLUSION : Thus, it can be concluded that the overall complication rate
was 9% and is considered safe enough at present as a mean of chemotherapy
administration that may help improve the quality of life for the patients with low rate
of complications.
Keywords: Breast cancer, chemotherapy, TIVAP , women, complications of TIVAP.
.
ii RINGKASAN
Kanker dikenal sebagai penyakit invasif yang muncul sebagai kumpulan
jaringan di organ dan dapat menyebabkan kematian. Berdasarkan data yang
diterbitkan oleh GLOBOCAN tahun 2012, jumlah kasus baru kanker payudara berada
pada posisi paling tinggi dengan angka kejadian mencapai 43,3%. Di Indonesia
sendiri, angka kejadian kanker payudara adalah 40 dari 100.000 wanita, dengan 50%
yang dating untuk berobat didiagnosa mengalami kanker stadium lanjut. Kematian
yang disebabkan oleh kanker payudara sendiri mencapai angka 15% dan merupakan
penyebab kematian kedua terbanyak setelah kanker paru dan kanker bronkus.
Kemoterapi sudah digunakan secara luas sebagai pilihan pengobatan bagi para
pasien kanker payudara karena tingginya angka keberhasilan kemoterapi. Namun,
beberapa obat kemoterapi memiliki resiko yang tidak dapat dihindari karena obatobatan kemoterapi tergolong dalam obat-obatan vesikan, iritan atau bahkan keduanya.
Ketika obat diadministrasikan melalui vena pasien, terutama melalui vena perifer
yang memiliki lumen yang sempit, maka kemungkinan ekstravasasi, abses pembuluh
darah, serta kematian jaringan bisa terjadi.
Penelitian dan pengembangan pun dilakukan sebagai solusi untuk mengatasi
kasus ini. TIVAP adalah salah satu alat untuk akses kemoterapi yang bisa digunakan
dalam waktu lama dan menguntungkan pasien yang membutuhkan kemoterapi jangka
panjang. TIVAP terdiri dari port yang ditanam di vena besar untuk memasukkan
obat-obatan, nutrisi, atau untuk pengambilan darah dan dapat digunakan sampai lebih
dari 3000 kali. Namun, TIVAP juga dapat menimbulkan komplikasi. Oleh karena itu,
penelitian ini dilakukan untuk mengevaluasi penggunaan serta mempelajari
komplikasi yang terjadi dari penggunaan TIVAP di RSUP Sanglah Denpasar.
Hasil dari penelitian pada pasien wanita dengan kanker payudara yang
menerima kemoterapi melalui TIVAP menunjukkan bahwa umur rerata pasoen
adalah di atas 40 tahun dan didiagnosa kanker payudara kiri, 61% pasien memilih
TIVAP atas keinginan pribadi untuk akses kemoterapi setelah diberikan KIE, dengan
rerata durasi port 324 hari, dan sebagian besar port diposisikan di vena subklavia
sebelah kanan. Prevalensi komplikasi pada pasien adalah 9% (total 3 kasus dari 28
pasien), jauh lebih kecil dari studi yang dilakukan di Turki dengan tingkat komplikasi
33,95%, dan menurun dibandingkan dnegan studi serupa yang telah dilakukan di
RSUP Sanglah oleh Sutrisna, dkk. pada tahun 2015 dengan hasil tingkat komlikasi
11%. Komplikasi yang ditemukan adalah satu kasus komplikasi awal berupa
blocking, dan komplikasi lanjut berupa exposed chemoport dan infeksi. Pada kasus
late complication, port pada pasien dilepas. Exposed chemoport sendiri merupakan
kasus baru di RSUP Sanglah setelah studi sebelumnya dilakukan. Tidak ada riwayat
keluhan pada pasien dengan komplikasi TIVAP setelah diterapi.
Penulis berharap penelitian ini berguna untuk menyediakan informasi
mengenai TIVAP dan komplikasinya di RSUP Sanglah Denpasar, Bali.
iii SUMMARY
Cancer is known as a very invasive disease that appears as building blocks of
tissue in body and lead to many deaths. Based on the data published by GLOBOCAN
in 2012, new cases of breast cancer had been the first leading cancer with the
percentage of 43,3%. In Indonesia alone, breast cancer incidence is 40 per 100.000
women, with 50% women who come for therapy are diagnosed with late stage breast
cancer. Whereas the deaths caused by Breast Cancer is reaching 15%, the second
highest cause of deaths in women with cancer after Lung and Bronchus Cancer
The chemotherapy treatment has been wide used to treat women with breast
cancer because of its high success rate. However, chemotherapy drugs have some
inevitable risks with them, as those drugs are categorized as vesicant, irritant, or both.
When it is inserted intravenously, especially the standard in Indonesia which use
peripheral intravenous line, it may lead to extravasation, vascular abscess, and even
worse tissue necrosis if left untreated.
As a solution, some new methods are introduced to avoid the incidence of
complications such as replacing peripheral IV line with TIVAP. TIVAP is a mean of
chemotherapy access that can be used continuously for a long time and especially
beneficial for patients with cancer who need numerous chemotherapy cycles during
their therapy. It has port placed in the larger vein to administer drug or taking blood
samples and can be used up to 3000 punctures. However, it also has a chance of
developing complication. Therefore this study was made to understand the use of
TIVAP and also its complications in RSUP Sanglah Denpasar.
Results of research on women with breast cancer who received chemotherapy
using TIVAP indicate that the average age is above 40, and mostly are diagnosed
with left breast cancer, 61% patients chose TIVAP based on personal preference after
given the education, with average port duration of 324 days, with most ports are
implanted in right subclavian vein. The prevalence of complications is 9% (3 cases
from 28 patients) far smaller to previous study done in Turkey of 33,95%
complication rate, and even decreasing compared to previous study done in Sanglah
Hospital by Sutrisna et al. in 2015 of 11%. The complications found were 1 case of
blocking as an early complication, exposed chemoport, and infection as late
complications. All late complications require port removal. Exposed chemoport is a
new case found in Sanglah. No further complaints post treatment regarding
complication is reported from any of the patients.
Hopefully this research is useful to provide information of TIVAP and its
complications in RSUP Sanglah Denpasar.
iv CONTENT
Report Cover ......................................................................................................... i
Validity Sheet ....................................................................................................... ii
Evaluating Committee Establishment ................................................................... iii
Preface ................................................................................................................... iv
Pernyataan Keaslian Karya Tulis Skripsi………………………………………...v
Abstrak Indonesia ………………………………………………………..………vi
Abstract English ………………………………………………………………....vii
Ringkasan………………………………………………………………………...viii
Summary…………………………………………………………………………ix
Content .................................................................................................................. viii
Table Lists ............................................................................................................. xi
List of Abbreviations or Signs .............................................................................. xii
CHAPTER I. Introduction .................................................................................... 1
1.1 ..................................................................................................... Backg
round ...................................................................................................... 4
1.2 ..................................................................................................... Resea
rch Problem............................................................................................ 4
1.3 Aims ....................................................................................................... 4
1.4 Benefit of Research................................................................................ 4
1.4.1 Academical .................................................................................. 4
1.4.2 Clinical......................................................................................... 4
CHAPTER II. Literature Review .......................................................................... 5
2.1 Breast Cancer ......................................................................................... 5
2.2 Treatment of Brain Metastases .............................................................. 11
2.3 Chemotherapy in Breast Cancer Treatment ........................................... 14
2.4 Administration Way of Chemotherapy Drugs ....................................... 17
2.5 Chemotherapy via Totally Implantable Venous Access Port………….22
v 2.6 Complications of Totally Implantable Venous Access Port .................. 25
CHAPTER III Conceptual Thinking ..................................................................... 28
CHAPTER IV Research Method .......................................................................... 30
4.1 Scope of Research.................................................................................. 30
4.1.1 Location of Research ..................................................................... 30
4.1.2 Time of Research ........................................................................... 30
4.1.3 Discipline of Research ................................................................... 30
4.2 Design of Research ................................................................................ 31
4.3 Research Population .............................................................................. 31
4.4 Variable of Research.............................................................................. 31
4.4.1 Variable Identification .................................................................. 31
4.4.2 Definition of Operational Variable ................................................ 31
4.5 Subject of Research .............................................................................. 33
4.5.1 Target Population ........................................................................... 33
4.5.2 Reach Population ........................................................................... 33
4.5.3 Research Sample ............................................................................ 33
4.6 Research Sample .................................................................................... 34
4.6.1 Total Sample .................................................................................. 34
4.6.2 Sampling Technique ...................................................................... 34
4.7 Research Instrument .............................................................................. 34
4.8 Data Collecting Method ......................................................................... 35
4.9 Analyzing and Making Research Data .................................................. 35
4.9.1 Making Research Result ................................................................ 35
4.9.2 Analyzing Research Data ............................................................... 35
4.10 The Ethic of Research .......................................................................... 35
CHAPTER V Result and Discussion .................................................................... 37
5.1 Result ..................................................................................................... 37
5.1.1 Result of Sample Characteristic ..................................................... 37
5.1.2 Result of Samples Chemoport Indication ...................................... 37
5.1.3 Result of Samples Chemoport Duration and
vi Chemoport Cycles during TIVAP Insertion ................................... 38
5.1.4 Result of Samples Chemoport Position ......................................... 39
5.1.5 Result of TIVAP Complications .................................................... 40
5.2 Discussion .............................................................................................. 40
CHAPTER VI Conclusion and Suggestion........................................................... 46
6.1 Conclusion ............................................................................................. 46
6.2 Suggestion.............................................................................................. 47
References ............................................................................................................. 48
vii TABLE LIST
Page Number
Table 1 Table of Anatomic Stage / Prognostic Groups
based on TNM staging system ……………………………………………. …8
Table 2 Table of Complications of Central Venous Line Insertion………….............20
Table 3 Table Classification of Chemotherapeutic Agent…………. ……………….22
Table 4 Table of Sample Characteristics…………………………………….. .......... 37
Table 5 Table of TIVAP Indication ............................................................................ 38
Table 6 Table of Chemoport Duration……………………………………………….39
Table 7 Table of Chemotherapy received by the Sample ………..………………….39
Table 8 Table of Chemoport Position …………….…..…………………………….39
Table 9 Table of TIVAP Complication……………………………………………...40
viii LIST OF ABBREVIATIONS OR SIGN
ABBREVIATIONS
TIVAP
:
Totally Implantable Venous Access Port
I.V.
:
Intravenous
AJCC
:
American Joint Committee on Cancer
PICC
:
Peripherally Inserted Central Catheter
RSUP
:
Rumah Sakit Umum Pusat
ACS
:
American Cancer Society
CVC
:
Central Venous Catheter
SIGN
%
to state number in percentage ix CHAPTER I
INTRODUCTION
1.1 Background
One of the most anticipated issue in medicine is cancer. Cancer is known as a
very invasive disease that appears as building blocks of tissue in bodyand lead to
many deaths. Based on the data published by GLOBOCAN , International Agency for
Research on Cancer (IARC) , on 2012 the number of new cancer cases found were
14.067.894 and there are 8.201.575 deaths caused by cancer worldwide. It is also
mentioned in the report that new cases of breast cancer in 2012 is the first leading
cancer with the percentage of 43,3%, and the percentage of deaths is 12,9%
(GLOBOCAN, 2012)
In Indonesia alone, breast cancer incidence is 40 per 100000 women, far higher
than cervix cancer incidence of 16 per 100000 (Kemenkes RI, 2015). In fact, most
breast cancer patients, 50% that go to receive management to doctors or hospitals are
already in late stage. The result of Indonesia Japan Collaborative Study about the
epidemiology of breast cancer is as follow : Stage I 2%, stage II 16%, Stage IIIa 23%,
Stage IIIb 40%, and Stage IV 19%. In late stage , refers to stage IIIB, inoperable
Stage IIIC, Stage IV, and metastatic breast cancer, the treatment options may include
chemotherapy, followed by surgery, and drug combinations(Eoemiatidkk.,2011)
In terms of patient selection thosewomen who had axillary node involvement at
the time of theirinitial surgery should be offered systemic adjuvant therapy, the size
of tumor and individual’s condition should be put into the consideration too. The
x effectiveness of chemotherapy has been acknowledged by many oncologist and made
it as an adjuvant therapy. It has been proved in many studies that chemotherapy
treatment such as cytotoxic agents is beneficial for treating an aggressive tumor, and
the patient’s with HER2 positive breast cancer may benefit from the administration of
trastuzumab.
However before we begin the treatment using chemotherapy agents, we need to
understand how to administer these drugs systematically. There are two common
ways of drug delivery , including venous lines and implantable port. Historically, the
veinpunctures have been used for ages ,but lately it has raised an issue of patient’s
discomfort , when they have to undergo injection quite few times to let the drug enter
the circulation. Some human errors are often reported in the registration of drugs via
veinpunctures, where the health practitioners need to find “good vein” by trials of
injecting another insufficient veins.
These findings are used by the scientists to improve the way of administering the
chemotherapy agents by using venous line. Venous line are fine hollow silicone
rubber catheter that is inserted in vein and stay throughout the time of chemotherapy.
There are several types of venous lines widely used in the clinical practice. First is
simple venous lines called cannula that is put in hand or arm and will systemically go
through blood stream via the vein of arm or hand. Second is the central line that is
inserted through the skin below the collar bone. It is then tunneled before entering the
subclavian vein, and threaded through this until its tip lies in the superior vena cava
above the heart. The third type is the PICC (Peripherally Inserted Central Catheter)
line. This line is inserted through large veins near the bend of the elbow and threaded
xi along through the subclavian vein into the superior vena cava. However specialists
begin to leave these venous lines modality because some complications are reported
late, following the insertion of lines, such as incidence of infection approximately
50% and 60 % case of asymptomatic thrombosis.
Implantable port or often called chemoport or porthocaths is a variation of
venous lines that are used as the alternative of PICC and central line venous lines.
The line is placed in similar way to central line but it ends in a subcutaneous port, so
it doesn’t coming out of skin. The port is made of soft plastic bubble , between 2,5
and 4 cm across and lies under the surface of the skin. The implantation is usually put
on chest and may be used to take blood sample and registering drugs just like the
conventional ones. It is reported to be better fixed on patients, more comfortable and
also minimizing the complications of other methods.
Breast cancer patients are increasing each year and chemotherapy is very
important and may last for few months to be registered to achieve the optimum
condition the patient may perceive. The discipline and comfort of the patients while
undergo the chemotherapy must be put into account to maximize the benefit of
chemotherapy. It can be achieved by using the right method of drug registration to
make it more comfortable, less stressful, and less painful. By the newly applied
implantable port method in Sanglah, Writer finds it important to understand the use of
Totally Implantable Venous Access Port in Breast Cancer patients who undergo
chemotherapy in RSUP Sanglah in 2015, to achieve understanding of this method
approval in breast cancer patients(Priestman, 2008).
xii 1.2 Research Problem
How is the overall evaluation of TIVAP use in breast cancer patients who
undergo chemotherapy in Rumah Sakit Umum Pusat Sanglah by 2015?
1.3 Aims
To evaluate the use of TIVAP for chemotherapy in breast cancer patients in
Rumah Sakit Umum Pusat Sanglah by 2015.
1.4 Benefits
This Research assumed to give benefit directly in the field of :
1.4.1
Academical
Reference
and
consideration,
also
development
in
administering
chemotherapy in breast cancer patients using Totally Implantable Venous
Access Port.
1.4.2
Clinical
Helping patients and doctors in deciding the best chemotherapy delivery
method and understanding more about the possible complications of TIVAP,
especially in breast cancer patients .
xiii