Are You in a Poor Country; HIPEC is Still in Reach

HIPEC Clinical Trial

Official title:

Are You in a Poor Country; HIPEC is Still in Reach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04664218
• Other study ID #: HIPEC is still in reach 2020
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: April 2020

Study information

• Verified date: December 2020
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Peritoneal carcinomatosis (PC) is a well-known sequel of multiple abdominal malignancies either arising from the gastro-intestinal tract or of gynaecologic origin. On occurrence, PC is mostly considered as a very bad prognostic sign hence it affects the overall survival with very poor response to systemic chemotherapy.

On introduction of the new concept of combined optimal cytoreduction (CRS) followed by hyperthermic intraperitoneal chemotherapy (HIPEC), promising prognosis began to be shown.

A major obstacle which may face application of HIPEC manoeuvre is the cost either of the machine or the disposable kit used in handling the chemotherapy, heating it and delivering it to the patient, hence we established our machine design with its disposable kits making it available for use in poor places.

Description:

As aforementioned the use of HIPEC technique offered a promising results in dealing with peritoneal carcinomatosis the high costs seems to be a considerable obstacle in some poor places so we inented a machine with considerably lower costs both in the machine composition and its disposable kit used for every patient we used it for six years in a trial to find any shortage, obstacles or any technical, therapeutic or financial drawbacks compared to the published data of the standard machines

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Any patient candidate for HIPEC procedure

Exclusion Criteria:

• Contraindications to HIPEC procedure

Related Conditions & MeSH terms

• HIPEC

Intervention

Device:
• HIPEC device
To report the affordability on using the HIPEC machine of our design compared to the standard ones in poor places.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thermal efficiency of the machine	The ability of the machine to warm the chemoperfusate to 43 c for 90 minutes (the duration of peritoneal perfusion)	6 years of the study using the machine
Primary	Electrical efficiency of the machine	Reporting any interruption or unexplained stop of the thermostat resulting in stopping of chemoperfusate flow to and out of the abdomen during the 90 minutes of the maneuver	6 years of the study using the machine
Primary	The manufacturing costs in US dollar	the costs paid by the owner of manufacturing the machine throughout collecting its components and technical fitting them into a machine	one weak at the start of the trial
Primary	The disposable costs in US dollar	the costs spent by the patient at each use paid for the disposable parts of the machine of the chemotherapy perfusion circuit to and from the patient	6 years of the study using the machine
Secondary	Adverse effects on the patient following HIPEC	following the patient in the postoperative period searching for adverse effects of HIPEC resulting from either the chemotherapy used or the physical activity of the machine	4 weeks