Gastric CancerNCT03780439
Procalcitonin to Predict Infection After Gastrectomy for Gastric Cancer
An observational study of Gastric Cancer, run by Yongchang Zhang at 1 site in China.
Trial summary
To investigate the diagnostic accuracy of procalcitonin as an early predictor of infection after radical gastrectomy for gastric cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- How many people
- 552 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 28 Jul 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pathologically diagnosed gastric adenocarcinoma who underwent radical gastrectomy.
Who may be able to join
- ≥ 18 years
- pathologically diagnosed gastric adenocarcinoma
- radical gastrectomy with lymphadenectomy.
Who cannot join
- ongoing infection at surgery
- pregnancy status
- underwent non-resection surgery
- underwent palliative gastrectomy
- emergency surgery
- taking corticosteroid or other immunosuppressive drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Accuracy of Procalcitonin as an Early Predictor of Infection After Radical Gastrectomy for Gastric Cancer: a Prospective Bi-center Study
To investigate the diagnostic accuracy of procalcitonin as an early predictor of infection after radical gastrectomy for gastric cancer.
Read the detailed description
From June 2018 to May 2019, consecutive eligible patients who underwent surgery for gastric cancer in the Department of Gastroduodenal and Pancreatic Surgery, Hunan Cancer Hospital and the treatment group of Professor Kai-xiong Tao in the Union Hospital of Tongji Medical College were invited to participate in the study. After surgery, routine blood test were measured morning on post-operative day (POD) 1, 3, 5, and 7, and serum level of procalcitonin was measured morning on POD 3 and 5.
The primary outcome of the present study was the accuracy of white blood cell (WBC) and neutrophil count, the neutrophil to WBC ratio (N%) and procalcitonin to detect post-operative infection (including intra-abdominal infection (IAI), surgical site infections (SSIs), pneumonia, urinary tract infection, catheter-related infection, and sepsis not specified) within 30 days after surgery. The main secondary outcome was their ability to detect any post-operative complications (such as intestinal obstruction, bleeding, ascites, cardiovascular and cerebrovascular events) within 30 days after surgery. Other secondary outcomes were the choice of the best timing to measure each inflammatory marker, the choice of a clinically meaningful cut-off value for the most accurate marker.
- Conditions
- Gastric Cancer
- Keywords
- procalcitonin, infection, gastric cancer, gastrectomy
- Medical subject headings
- Stomach Neoplasms, Infections
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 |
|---|---|---|
| infection group and non-infection group | patients were divided into 2 sub-groups according to the presence of infection or not after radical gastrectomy for gastric cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic accuracy of procalcitonin to detect post-operative infection
the accuracy of procalcitonin to detect post-operative infection
Measured: within 30 days after surgery
Secondary outcomes (1)
diagnostic accuracy of procalcitonin to detect overall post-operative complications
the accuracy of procalcitonin to detect any post-operative complications
Measured: within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Jun 2018
- Primary completion28 Jul 2019
- Study completion28 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies 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
- Prospective
- Enrolment
- 552 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yongchang Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- Huazhong University of Science and Technology
- Responsible party
- Sponsor-investigator, Yongchang Zhang, Hunan Province Tumor Hospital
- Investigators
- Hua Xiao, Principal investigator, Hunan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780439
- Sponsor's protocol ID
- PCT-INFECTION
- Status last verified
- Sep 2019
- First submitted
- 13 Dec 2018
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Facy O, Paquette B, Orry D, Binquet C, Masson D, Bouvier A, Fournel I, Charles PE, Rat P, Ortega-Deballon P; IMACORS Study. Diagnostic Accuracy of Inflammatory Markers As Early Predictors of Infection After Elective Colorectal Surgery: Results From the IMACORS Study. Ann Surg. 2016 May;263(5):961-6. doi: 10.1097/SLA.0000000000001303.
PubMed 26135691Cousin F, Ortega-Deballon P, Bourredjem A, Doussot A, Giaccaglia V, Fournel I. Diagnostic Accuracy of Procalcitonin and C-reactive Protein for the Early Diagnosis of Intra-abdominal Infection After Elective Colorectal Surgery: A Meta-analysis. Ann Surg. 2016 Aug;264(2):252-6. doi: 10.1097/SLA.0000000000001545.
PubMed 27049766Xiao H, Quan H, Pan S, Yin B, Luo W, Huang G, Ouyang Y. Impact of peri-operative blood transfusion on post-operative infections after radical gastrectomy for gastric cancer: a propensity score matching analysis focusing on the timing, amount of transfusion and role of leukocyte depletion. J Cancer Res Clin Oncol. 2018 Jun;144(6):1143-1154. doi: 10.1007/s00432-018-2630-8. Epub 2018 Mar 23.
PubMed 29572591Munoz JL, Ruiz-Tovar J, Miranda E, Berrio DL, Moya P, Gutierrez M, Flores R, Pico C, Perez A. C-Reactive Protein and Procalcitonin as Early Markers of Septic Complications after Laparoscopic Sleeve Gastrectomy in Morbidly Obese Patients Within an Enhanced Recovery After Surgery Program. J Am Coll Surg. 2016 May;222(5):831-7. doi: 10.1016/j.jamcollsurg.2016.01.059. Epub 2016 Feb 13.
PubMed 27010585
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Procalcitonin as an Early Predictor of Infection After Radical Gastrectomy for Gastric Cancer: a Prospective Bi-center Study
- ClinicalTrials.gov ID
- NCT03780439
- Acronym / sponsor ID
- PCT-INFECTION
- Conditions
- Gastric Cancer
- Keywords
- procalcitonin, infection, gastric cancer, gastrectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 552 participants (actual)
- Lead sponsor
- Yongchang ZhangUniversity, hospital or other
- Collaborators
- Huazhong University of Science and Technology
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 28 Jul 2019 (actual)
- Study completion
- 28 Jul 2019 (actual)
- First posted
- 19 Dec 2018 (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.
To investigate the diagnostic accuracy of procalcitonin as an early predictor of infection after radical gastrectomy for gastric cancer.
Detailed description
From June 2018 to May 2019, consecutive eligible patients who underwent surgery for gastric cancer in the Department of Gastroduodenal and Pancreatic Surgery, Hunan Cancer Hospital and the treatment group of Professor Kai-xiong Tao in the Union Hospital of Tongji Medical College were invited to participate in the study. After surgery, routine blood test were measured morning on post-operative day (POD) 1, 3, 5, and 7, and serum level of procalcitonin was measured morning on POD 3 and 5.
The primary outcome of the present study was the accuracy of white blood cell (WBC) and neutrophil count, the neutrophil to WBC ratio (N%) and procalcitonin to detect post-operative infection (including intra-abdominal infection (IAI), surgical site infections (SSIs), pneumonia, urinary tract infection, catheter-related infection, and sepsis not specified) within 30 days after surgery. The main secondary outcome was their ability to detect any post-operative complications (such as intestinal obstruction, bleeding, ascites, cardiovascular and cerebrovascular events) within 30 days after surgery. Other secondary outcomes were the choice of the best timing to measure each inflammatory marker, the choice of a clinically meaningful cut-off value for the most accurate marker.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| infection group and non-infection group | – | –patients were divided into 2 sub-groups according to the presence of infection or not after radical gastrectomy for gastric cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pathologically diagnosed gastric adenocarcinoma who underwent radical gastrectomy.
Key inclusion criteria (3 listed)
- ≥ 18 years
- pathologically diagnosed gastric adenocarcinoma
- radical gastrectomy with lymphadenectomy.
Key exclusion criteria (6 listed)
- ongoing infection at surgery
- pregnancy status
- underwent non-resection surgery
- underwent palliative gastrectomy
- emergency surgery
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
diagnostic accuracy of procalcitonin to detect post-operative infection
Time frame: within 30 days after surgery
the accuracy of procalcitonin to detect post-operative infection
1 secondary outcome
diagnostic accuracy of procalcitonin to detect overall post-operative complications
Time frame: within 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Results publication: PubMed 26135691Facy O, Paquette B, Orry D, Binquet C, Masson D, Bouvier A, Fournel I, Charles PE, Rat P, Ortega-Deballon P; IMACORS Study. Diagnostic Accuracy of Inflammatory Markers As Early Predictors of Infection After Elective Colorectal Surgery: Results From the IMACORS Study. Ann Surg. 2016 May;263(5):961-6. doi: 10.1097/SLA.0000000000001303.
- Results publication: PubMed 27049766Cousin F, Ortega-Deballon P, Bourredjem A, Doussot A, Giaccaglia V, Fournel I. Diagnostic Accuracy of Procalcitonin and C-reactive Protein for the Early Diagnosis of Intra-abdominal Infection After Elective Colorectal Surgery: A Meta-analysis. Ann Surg. 2016 Aug;264(2):252-6. doi: 10.1097/SLA.0000000000001545.
- Results publication: PubMed 29572591Xiao H, Quan H, Pan S, Yin B, Luo W, Huang G, Ouyang Y. Impact of peri-operative blood transfusion on post-operative infections after radical gastrectomy for gastric cancer: a propensity score matching analysis focusing on the timing, amount of transfusion and role of leukocyte depletion. J Cancer Res Clin Oncol. 2018 Jun;144(6):1143-1154. doi: 10.1007/s00432-018-2630-8. Epub 2018 Mar 23.
- Results publication: PubMed 27010585Munoz JL, Ruiz-Tovar J, Miranda E, Berrio DL, Moya P, Gutierrez M, Flores R, Pico C, Perez A. C-Reactive Protein and Procalcitonin as Early Markers of Septic Complications after Laparoscopic Sleeve Gastrectomy in Morbidly Obese Patients Within an Enhanced Recovery After Surgery Program. J Am Coll Surg. 2016 May;222(5):831-7. doi: 10.1016/j.jamcollsurg.2016.01.059. Epub 2016 Feb 13.
- Individual participant dataSharing planned: No
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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.
Hua Xiao principal investigator
Hunan Cancer 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 Gastric Cancer, run by Yongchang Zhang at 1 site in China.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 24 Sep 2019. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
diagnostic accuracy of procalcitonin to detect post-operative infection (time frame: within 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03780439, which also lists 4 linked publications.
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 24 Sep 2019.