Gastric CancerNCT02756455
Procalcitonin Reveals Early Dehiscence in Gastric Surgery: the PREDIGS Study
An observational study of Gastric Cancer, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
Background. Gastric cancer surgery is associated with high risk for postoperative morbidity and mortality. Anastomotic leak (AL) is one of the worst complications associated with relevant short and long-term sequelae. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- gastric cancer pts undergoing surgery
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2015to Dec 2016
- How long will I take part?
- 2 Years
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing gastric cancer surgery in our institution
Who may be able to join
- patients undergoing all different kinds of gastric surgery (from partial to total gastrectomy) for cancer, WITH an anastomosis performed
- elective setting
Who cannot join
- age < 18 years
- pregnant women
- patients undergoing gastric surgery for benign disease or other kinds of gastric surgery without an anastomosis being performed
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Sant'Andrea University Hospital
Rome, 00189
Valentina Giaccaglia, MD, 00393397882429, v.giaccaglia@gmail.com
Valentina Giaccaglia, MD
About this study
Official title: Procalcitonin Reveals Early Dehiscence In Gastric Surgery: the PREDIGS Study
Background. Gastric cancer surgery is associated with high risk for postoperative morbidity and mortality. Anastomotic leak (AL) is one of the worst complications associated with relevant short and long-term sequelae. Procalcitonin (PCT) is a biomarker used to monitor bacterial infections and guide antibiotic therapy and has been shown to have better predictive value of AL after colorectal surgery than C-reactive protein (CRP) and white blood cell count (WBC).
Purpose. Investigators designed a monocentric pilot study to test if PCT might be a sensitive and reliable marker of AL after gastric surgery
- Conditions
- Gastric Cancer
- Being tested
- gastric cancer pts undergoing surgery
- Keywords
- gastric cancer, procalcitonin
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastric cancer pts undergoing surgeryOther
Measure PCT (procalcitonin), CRP (C-reactive protein) and WBC (white blood cell count) in 3rd and 5th postoperative day and registration of all intra and postoperative complications
| Study group | Role | What they receive |
|---|---|---|
| gastric cancer pts undergoing surgery | all pts receiving gastric resection for cancer, with anastomosis Receives: Other: gastric cancer pts undergoing surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of patients with leaks after gastric surgery correctly identified by the biomarkers (PCT and CRP)
PCT: procalcitonin, CRP: C-reactive protein
Measured: 2 years
% of patients without leaks after gastric surgery correctly identified by PCT and CRP
PCT: procalcitonin, CRP: C-reactive protein
Measured: 2 years
Secondary outcomes (2)
PCT cut-off that gives good negative predictive (NPV) value for leak after gastric surgery in 3rd POD
procalcitonin (PCT) cuts-off in 3rd post-operative day (POD) with a good NPV
Measured: 2 years
PCT cut-off that gives good negative predictive value for leak after gastric surgery in 5th POD
PCT cuts-off in 5th POD with a good NPV
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startJan 2015
- Primary completionJun 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valentina Giaccaglia, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756455
- Sponsor's protocol ID
- PREDIGS
- Status last verified
- Apr 2016
- First submitted
- 18 Apr 2016
- Last updated
- 29 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procalcitonin Reveals Early Dehiscence In Gastric Surgery: the PREDIGS Study
- ClinicalTrials.gov ID
- NCT02756455
- Acronym / sponsor ID
- PREDIGS
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, procalcitonin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 29 Apr 2016 (estimated)
- 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.
Background. Gastric cancer surgery is associated with high risk for postoperative morbidity and mortality. Anastomotic leak (AL) is one of the worst complications associated with relevant short and long-term sequelae. Procalcitonin (PCT) is a biomarker used to monitor bacterial infections and guide antibiotic therapy and has been shown to have better predictive value of AL after colorectal surgery than C-reactive protein (CRP) and white blood cell count (WBC).
Purpose. Investigators designed a monocentric pilot study to test if PCT might be a sensitive and reliable marker of AL after gastric surgery
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gastric cancer pts undergoing surgery | – | Other: gastric cancer pts undergoing surgeryall pts receiving gastric resection for cancer, with anastomosis |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing gastric cancer surgery in our institution
Key inclusion criteria (2 listed)
- patients undergoing all different kinds of gastric surgery (from partial to total gastrectomy) for cancer, WITH an anastomosis performed
- elective setting
Key exclusion criteria (3 listed)
- age < 18 years
- pregnant women
- patients undergoing gastric surgery for benign disease or other kinds of gastric surgery without an anastomosis being performed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gastric cancer pts undergoing surgeryMeasure PCT (procalcitonin), CRP (C-reactive protein) and WBC (white blood cell count) in 3rd and 5th postoperative day and registration of all intra and postoperative complications | Other | gastric cancer pts undergoing surgery |
Primary outcome
% of patients with leaks after gastric surgery correctly identified by the biomarkers (PCT and CRP)
Time frame: 2 years
PCT: procalcitonin, CRP: C-reactive protein
% of patients without leaks after gastric surgery correctly identified by PCT and CRP
Time frame: 2 years
PCT: procalcitonin, CRP: C-reactive protein
2 secondary outcomes
PCT cut-off that gives good negative predictive (NPV) value for leak after gastric surgery in 3rd POD
Time frame: 2 years
PCT cut-off that gives good negative predictive value for leak after gastric surgery in 5th POD
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2016.
- 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.
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 University of Roma La Sapienza at 1 site in Italy.
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 2 inclusion and 3 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 29 Apr 2016. 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 Italy. 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?
Contact Valentina Giaccaglia, MD (+393397882429, v.giaccaglia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of patients with leaks after gastric surgery correctly identified by the biomarkers (PCT and CRP) (time frame: 2 years). The study lists 2 primary outcomes in all. 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 29 Apr 2016.