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Clinical Pharmacology of Platinum-based Hyperthermic Intraperitoneal Chemotherapy

Зөвхөн бүртгэлтэй хэрэглэгчид л нийтлэл орчуулах боломжтой
Нэвтрэх / Бүртгүүлэх
Холбоосыг санах ойд хадгалдаг
СтатусДууссан
Ивээн тэтгэгчид
Radboud University

Түлхүүр үгс

Хураангуй

Currently, there is a lack of knowledge on the effect of additional flushing after HIPEC on tumour platinum exposure, systemic platinum exposure and platinum concentration in drain exudate and thereby personal exposure. Therefore the investigators want to perform a study to investigate the effect of flushing after HIPEC on tumour exposure, systemic exposure and on wound exudate concentration.

Тодорхойлолт

Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC) is standard care in the treatment of patients with peritoneal carcinomatosis as a result of intra-abdominal cancers. In many (inter)national centres oxaliplatin is used for the primary HIPEC treatment. Although the oxaliplatin dose of 460mg/m2 is widely accepted, the exact procedure of HIPEC differs between institutions and surgeons. Due to a great variety in the volume of the abdominal cavity, platinum concentration in the perfusate might differ between patients. Moreover, there is no consensus about the usefulness of flushing the HIPEC system with crystalloids at the end of oxaliplatin administration. Flushing is predominantly performed with the idea to minimize both systemic exposure of ultrafilterable platinum and personnel exposure to platinum contaminated exudate. On the other hand, HIPEC without flushing might increase effectiveness because intraperitoneal tumour cells are exposed to high concentrations of oxaliplatin for a longer time period. The option of flushing is based on an individual preference of the surgeon. Currently, there is a lack of knowledge on the effect of flushing on tumour platinum exposure, systemic platinum exposure and platinum concentration in drain exudate and thereby personal exposure. Therefore the investigators want to perform a study to investigate the effect of flushing after HIPEC on tumour exposure, systemic exposure and on wound exudate concentration.

Огноо

Сүүлд баталгаажуулсан: 06/30/2020
Эхлээд оруулсан: 10/01/2017
Тооцоолсон элсэлтийг оруулсан: 12/05/2017
Эхлээд нийтэлсэн: 12/06/2017
Сүүлийн шинэчлэлтийг оруулсан: 07/08/2020
Сүүлийн шинэчлэлтийг нийтэлсэн: 07/09/2020
Сургалтын бодит эхлэх огноо: 02/28/2018
Тооцоолсон анхан шатны ажил дуусах огноо: 06/07/2019
Судалгааны ажлыг дуусгах өдөр: 12/29/2019

Нөхцөл байдал эсвэл өвчин

Peritoneal Carcinomatosis

Хөндлөнгийн оролцоо / эмчилгээ

Other: HIPEC patients

Other: HIPEC patients

Үе шат

-

Arm Groups

ГарХөндлөнгийн оролцоо / эмчилгээ
HIPEC patients
Patients with a diagnosis of peritoneal carcinomatosis who undergo HIPEC treatment with oxaliplatin.
Other: HIPEC patients
flushing with saline fluid after HIPEC

Эрхийн шалгуур

Суралцах боломжтой нас 18 Years Хэнд 18 Years
Суралцах боломжтой хүйсAll
Дээж авах аргаNon-Probability Sample
Эрүүл сайн дурын ажилтнуудыг хүлээн авдагТийм ээ
Шалгуур үзүүлэлтүүд

Inclusion Criteria:

1. Subjects must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow-up.

Note: Informed consent may be obtained prior to start of the specified screening window.

Note: Procedures conducted as part of the subject's routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes.

2. Age ≥ 18 years

3. Confirmed diagnosis of preoperatively identifi ed primary or recurrent peritoneal carcinomatosis (PC) of colorectal origin who are planned for HIPEC treatment with oxaliplatin according to routine clinical care

Exclusion Criteria:

1) Patients who do not achieve a cytoreduction score of CC-0 will be excluded from the study.

Үр дүн

Анхан шатны үр дүнгийн арга хэмжээ

1. change in tissue platinum exposure before and after flushing [immediately after the oxaliplatin instillate solution is withdrawn from the abdominal cavity and immediately after additional flushing is performed. This takes all place within 1 hour after the start of HIPEC.]

Change in tissue platinum exposure of non-tumour peritoneal tissue sample before and after flushing with saline

Хоёрдогч үр дүнгийн арга хэмжээ

1. wound exudate platinum concentration [until day 3 post-HIPEC]

platinum concentration in wound exudate samples will be measured in the drains

2. systemic exposure of total and unbound platinum [until day 3 post-HIPEC]

systemic exposure of total and unbound platinum will be measured using 13 blood samples

3. total and unbound platinum concentration in instillate [all samples will be taken within 30 minutes during the HIPEC procedure]

total and unbound platinum concentration in instillate will be measured in 3 samples of instillate solution that will be obtained during the HIPEC procedure

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