Ignite Creation Date:
2024-05-06 @ 1:24 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04014426
Status:
COMPLETED
Last Update Posted:
2019-07-10
First Post:
2019-07-01
Brief Title:
Evaluation of Healthcare Workers Safety During Pressurized Intraperitoneal Aerosol Chemotherapy
Sponsor:
Institut du Cancer de Montpellier - Val dAurelle
Organization:
Institut du Cancer de Montpellier - Val dAurelle
Study Overview
Official Title:
Evaluation of Oxaliplatin Exposure and Security of Healthcare Workers During Pressurized Intraperitoneal Aerosol Chemotherapy
Status:
COMPLETED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PIPAC-Secure
Brief Summary:
Pressurized intraperitoneal aerosol chemotherapy PIPAC is a new treatment that applies chemotherapeutic drugs into the peritoneal cavity as an aerosol It is used to treat patient with Peritoneal Carcinomatosis PC During this procedure healthcare workers may be under risks of exposure to cytotoxic treatments
The purpose of this study is to evaluate the safety of the heathcare workers and the risk of operation room Oxaliplatins contamination during a PIPAC
The purpose of this study is to evaluate the safety of the heathcare workers and the risk of operation room Oxaliplatins contamination during a PIPAC
Detailed Description:
Peritoneal carcinomatosis PC which was long considered as a terminal stage is now potentially curable Nevertheless in most cases the surgical treatment of PC is limited by the disease extent which is commonly measured with the Peritoneal Carcinomatosis Index PCI For the patients that are not considered good candidates for resection there are very few alternatives Systemic chemotherapy may have limited or no effect therefore an alternative solution is needed for these patients
Pressurized intraperitoneal aerosol chemotherapy PIPAC is a new treatment that applies chemotherapeutic drugs into the peritoneal cavity as an aerosol under pressure through minimal laparoscopic surgery
Nevertheless as it is the case for most technologies security is not always completely tested The innovative team started by establishing a set of security rules that concern the operating room ventilation distance monitoring of the patient during nebulization evacuation of the aerosols in a closed system In a work dedicated to occupational hazards the authors followed the following steps identification of hazardous substances and dose identification of possible exposure ways simulation of the PIPAC procedure with nontoxic aerosols and smoke redaction of standard operating procedures SOP second simulation according to the SOP informing and training the health care workers and performance of the first two PIPAC procedures with chemotherapeutic substances and workplace measurements under real conditions At the end of the study there were no traces of doxorubicin or cisplatin the two drugs used in the two consecutive test procedures in the operating room air neither to the position of the anesthesiologist nor of the surgeon
This study does not concern PIPAC with oxaliplatin nor does it research the presence of the drugs in the health caregivers
Therefore we considered mandatory to further investigate occupational hazards in the specific case of oxaliplatin by focusing more on the healthcare workers and partially applying the same protocols as in the case of Heated intraperitoneal chemotherapy HIPEC
Pressurized intraperitoneal aerosol chemotherapy PIPAC is a new treatment that applies chemotherapeutic drugs into the peritoneal cavity as an aerosol under pressure through minimal laparoscopic surgery
Nevertheless as it is the case for most technologies security is not always completely tested The innovative team started by establishing a set of security rules that concern the operating room ventilation distance monitoring of the patient during nebulization evacuation of the aerosols in a closed system In a work dedicated to occupational hazards the authors followed the following steps identification of hazardous substances and dose identification of possible exposure ways simulation of the PIPAC procedure with nontoxic aerosols and smoke redaction of standard operating procedures SOP second simulation according to the SOP informing and training the health care workers and performance of the first two PIPAC procedures with chemotherapeutic substances and workplace measurements under real conditions At the end of the study there were no traces of doxorubicin or cisplatin the two drugs used in the two consecutive test procedures in the operating room air neither to the position of the anesthesiologist nor of the surgeon
This study does not concern PIPAC with oxaliplatin nor does it research the presence of the drugs in the health caregivers
Therefore we considered mandatory to further investigate occupational hazards in the specific case of oxaliplatin by focusing more on the healthcare workers and partially applying the same protocols as in the case of Heated intraperitoneal chemotherapy HIPEC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None