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Completed

NCT Number: NCT04664218

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.

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Key information

Conditions

HIPEC

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any patient candidate for HIPEC procedure

Exclusion criteria

  • Contraindications to HIPEC procedure

Treatment and study plan

HIPEC device

Device

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

Primary outcomes

  1. Thermal efficiency of the machine

    Time frame: 6 years of the study using the machine

    The ability of the machine to warm the chemoperfusate to 43 c for 90 minutes (the duration of peritoneal perfusion)

  2. Electrical efficiency of the machine

    Time frame: 6 years of the study using 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

  3. The manufacturing costs in US dollar

    Time frame: one weak at the start of the trial

    the costs paid by the owner of manufacturing the machine throughout collecting its components and technical fitting them into a machine

  4. The disposable costs in US dollar

    Time frame: 6 years of the study using the machine

    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

Secondary outcomes

  1. Adverse effects on the patient following HIPEC

    Time frame: 4 weeks

    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

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Dec 11, 2020
Registry last updated
Dec 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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