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

NCT04664218 | Completed

• 1 other identifier: HIPEC is still in reach 2020
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

HIPEC

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (1)

• Adverse effects on the patient following HIPEC

  4 weeks

Study Arms (1)

patients with Peritoneal carcinomatosis

EXPERIMENTAL

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.

Device: HIPEC device

Interventions

HIPEC device DEVICE

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

patients with Peritoneal carcinomatosis

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient candidate for HIPEC procedure

You may not qualify if:

• Contraindications to HIPEC procedure

Sponsors & Collaborators

• Zagazig University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 24, 2020
• First Posted: December 11, 2020
• Study Start: January 1, 2014
• Primary Completion: January 1, 2020
• Study Completion: April 1, 2020
• Last Updated: December 11, 2020

Record last verified: 2020-12