Cytoreductive Surgery With Hyperthermic Intraperitoneal ChemotherapyNCT03218449
Inflammatory Markers for Postoperative Complications in Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
An observational study of Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
Infective complications after cancer surgery had a significant impact on disease-free and overall survival. Postoperative inflammatory markers have been proven useful in predicting infective complications. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Jun 2017to 30 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Between September 2014 and April 2017, all patients who underwent cytoreductive surgery and HIPEC for peritoneal carcinomatosis
Who may be able to join
- Between September 2014 and April 2017, all patients who underwent cytoreductive surgery and HIPEC for peritoneal carcinomatosis
Who cannot join
- A Patient treated the dexmedetomidine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prognostic Value of Inflammatory Markers for Postoperative Complications in Patients Undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Infective complications after cancer surgery had a significant impact on disease-free and overall survival. Postoperative inflammatory markers have been proven useful in predicting infective complications. However, it remains unknown whether these markers can predict postoperative infection in patients receiving cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) which causes the systemic inflammatory response syndrome. Between September 2014 and April 2017, all patients who underwent cytoreductive surgery and HIPEC for peritoneal carcinomatosis were assessed for postoperative complications. Patients were divided into two groups according to the presence of infective complications. Presence of abscess, positive blood, surgical site, urine or sputum cultures, or clinical signs and symptoms with comparable radiologic findings were defined as infective complications. Retrospectively, C-reactive protein (CRP), neutrophil-to-lymphocyte ratio, white blood cell count, platelet count, mean platelet volume, platelet-to-lymphocyte ratio, albumin were collected from preoperative day and postoperative days (POD) 0-14.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1/NC | noninfective complication | |
| 2/IC | infective complication |
What is being measured
The primary outcome is the main question the study is designed to answer.
inflammatory markers
Retrospectively, C-reactive protein (CRP), neutrophil-to-lymphocyte ratio, white blood cell count, platelet count, mean platelet volume, platelet-to-lymphocyte ratio, albumin were collected using electronic medical record from preoperative day and postoperative days (POD) 0-14.
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start13 Jun 2017
- Primary completion31 Oct 2017 (estimated)
- Study completion30 Nov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytoreductive Surgery With Hyperthermic Intraperitoneal ChemotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yon Hee Shim, Gangnam Severance Hospital
- Investigators
- Yon Hee Shim, Principal investigator, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218449
- Sponsor's protocol ID
- 3-2017-0053
- Status last verified
- Jul 2017
- First submitted
- 22 Jun 2017
- Last updated
- 14 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Value of Inflammatory Markers for Postoperative Complications in Patients Undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
- ClinicalTrials.gov ID
- NCT03218449
- Acronym / sponsor ID
- 3-2017-0053
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 13 Jun 2017 (actual)
- Primary completion
- 31 Oct 2017 (estimated)
- Study completion
- 30 Nov 2017 (estimated)
- First posted
- 14 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Infective complications after cancer surgery had a significant impact on disease-free and overall survival. Postoperative inflammatory markers have been proven useful in predicting infective complications. However, it remains unknown whether these markers can predict postoperative infection in patients receiving cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) which causes the systemic inflammatory response syndrome. Between September 2014 and April 2017, all patients who underwent cytoreductive surgery and HIPEC for peritoneal carcinomatosis were assessed for postoperative complications. Patients were divided into two groups according to the presence of infective complications. Presence of abscess, positive blood, surgical site, urine or sputum cultures, or clinical signs and symptoms with comparable radiologic findings were defined as infective complications. Retrospectively, C-reactive protein (CRP), neutrophil-to-lymphocyte ratio, white blood cell count, platelet count, mean platelet volume, platelet-to-lymphocyte ratio, albumin were collected from preoperative day and postoperative days (POD) 0-14.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1/NC | – | –noninfective complication |
| 2/IC | – | –infective complication |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Between September 2014 and April 2017, all patients who underwent cytoreductive surgery and HIPEC for peritoneal carcinomatosis
Key inclusion criteria (1 listed)
- Between September 2014 and April 2017, all patients who underwent cytoreductive surgery and HIPEC for peritoneal carcinomatosis
Key exclusion criteria (1 listed)
- A Patient treated the dexmedetomidine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
inflammatory markers
Time frame: up to 2 weeks
Retrospectively, C-reactive protein (CRP), neutrophil-to-lymphocyte ratio, white blood cell count, platelet count, mean platelet volume, platelet-to-lymphocyte ratio, albumin were collected using electronic medical record from preoperative day and postoperative days (POD) 0-14.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yon Hee Shim principal investigator
Gangnam Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy, run by Gangnam Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inflammatory markers (time frame: up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2017.