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

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.

Study Overview

• Status: Completed
• Conditions: HIPEC
• Intervention / Treatment: Device: HIPEC device

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Any patient candidate for HIPEC procedure

Exclusion Criteria:

• Contraindications to HIPEC procedure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: patients with Peritoneal carcinomatosis; 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; To report the affordability on using the HIPEC machine of our design compared to the standard ones in poor places.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2014
• Primary Completion (ACTUAL): January 1, 2020
• Study Completion (ACTUAL): April 1, 2020

Study Registration Dates

• First Submitted: October 24, 2020
• First Submitted That Met QC Criteria: December 4, 2020
• First Posted (ACTUAL): December 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 11, 2020
• Last Update Submitted That Met QC Criteria: December 4, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: HIPEC is still in reach 2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No