An observational study in Peritoneal Carcinomatosis, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-20.
Sponsored by Radboud University Medical Center · Observational
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.
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.
249 studies on the registry are indexed under Peritoneal Neoplasms; 55 are open to participants now.
This study's enrollment of 20 is below the median of 100 across 43 observational studies indexed under Peritoneal Neoplasms.
Browse Peritoneal Neoplasms studies →Radboud University Medical Center is the lead sponsor of 986 studies on the registry; 136 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Patients diagnosed with peritoneal carcinomatosis who undergo HIPEC treatment with oxaliplatin as part of routine care.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects must provide written 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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with a diagnosis of peritoneal carcinomatosis who undergo HIPEC treatment with oxaliplatin.
Other: HIPEC with flushing afterwards · Other: HIPEC without flushing afterwards
flushing with saline fluid after HIPEC
NO flushing with saline fluid after HIPEC
change in tissue platinum exposure before and after flushing
Change in tissue platinum exposure of non-tumour peritoneal tissue sample before and after flushing with saline
Time frame: 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.
wound exudate platinum concentration
platinum concentration in wound exudate samples will be measured in the drains
Time frame: until day 3 post-HIPEC
systemic exposure of total and unbound platinum
systemic exposure of total and unbound platinum will be measured using 13 blood samples
Time frame: until day 3 post-HIPEC
total and unbound platinum concentration in instillate
total and unbound platinum concentration in instillate will be measured in 3 samples of instillate solution that will be obtained during the HIPEC procedure
Time frame: all samples will be taken within 30 minutes during the HIPEC procedure
Plan to share: No
Ran from Mar 2018 to primary completion in Jun 2019, 15 months.
Of 23 observational studies under Peritoneal Neoplasms, half reached primary completion within 71 months of starting (the median), counting those still running; a quarter within 23. This study's 15 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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