Gastric CancerNCT04791293
The Model for End-Stage Liver Disease Sodium (MELD-Na) Score in Non-cirrhotic Patients With Gastric Cancer
An observational study of Gastric Cancer and Complication,Postoperative, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Gastric cancer is the fifth most common cancer worldwide. Gastrectomy with lymphadenectomy is still the most effective treatment modality, depending on the stage and location. Despite many radiological, surgical and anesthetic innovations, serious complications such as anastomotic leakage, intra-abdominal abscesses… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer, Complication,Postoperative, Complications; Gastrointestinal, Postoperative
- What is being tested?
- MELD-Na score
- How many people
- 159 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2020to 5 Aug 2022
- How long will I take part?
- 1 Month
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing gastrectomy due to gastric cancer
Who may be able to join
- Patients undergoing gastrectomy due to gastric cancer
Who cannot join
- Patients with pulmonary, hepatic and renal disfunctions,
- Patients with diagnosed with a different cancer in the last 5 years and
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Training and Research Hospital
Istanbul, 34029
About this study
Official title: Predictive Value of MELD-Na Score for Perioperative Complications in Non-cirrhotic Patients With Gastric Cancer
Gastric cancer is the fifth most common cancer worldwide. Gastrectomy with lymphadenectomy is still the most effective treatment modality, depending on the stage and location. Despite many radiological, surgical and anesthetic innovations, serious complications such as anastomotic leakage, intra-abdominal abscesses, wound complications are seen secondary to gastrectomy. Many clinical studies have been conducted to prevent and predict these complications.
The Model for End-Stage Liver Disease (MELD) score, in which bilirubin, international normalized ratio (INR) and serum creatinine values were used to determine surgical risks in patients scheduled for liver transplantation. Latter developed by adding serum sodium (Na) to the formula. The MELD-Na score is used to predict postoperative complications in non-cirrhotic patients because of its simple and easy calculation.Moreover, The Meld-Na score was later used to predict complications for surgical procedures other than liver surgery such as colorectal surgery.
In this study, we aimed to investigate the importance of the Meld-Na score in predicting the perioperative and postoperative outcomes in patients with gastric cancer.
- Conditions
- Gastric Cancer, Complication,Postoperative, Complications; Gastrointestinal, Postoperative, Morality
- Being tested
- MELD-Na score
- Medical subject headings
- Stomach Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MELD-Na scoreOther
MELD-Na scores will be compared between the groups
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with postoperative complications Receives: Other: MELD-Na score | |
| Group 2 | Patients without postoperative complications Receives: Other: MELD-Na score |
What is being measured
The primary outcome is the main question the study is designed to answer.
MELD-Na score difference between the groups
Importance of MELD-Na score in predicting postoperative complications in patients with gastric cancer
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start1 Dec 2020
- Primary completion5 Aug 2022
- Study completion5 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 159 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Cihad Tatar, Istanbul Training and Research Hospital
- Investigators
- Cihad Tatar, MD, Principal investigator, Istanbul Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791293
- Sponsor's protocol ID
- 2630
- Status last verified
- Aug 2022
- First submitted
- 6 Mar 2021
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Coakley KM, Sarasani S, Prasad T, Steele SR, Paquette I, Heniford BT, Davis BR. MELD-Na Score as a Predictor of Anastomotic Leak in Elective Colorectal Surgery. J Surg Res. 2018 Dec;232:43-48. doi: 10.1016/j.jss.2018.04.012. Epub 2018 Jul 2.
PubMed 30463752Schlosser KA, Kao AM, Zhang Y, Prasad T, Kasten KR, Davis BR, Heniford BT, Colavita PD. MELD-Na score associated with postoperative complications in hernia repair in non-cirrhotic patients. Hernia. 2019 Feb;23(1):51-59. doi: 10.1007/s10029-018-1849-2. Epub 2018 Nov 16.
PubMed 30446849Yasri S, Wiwanitkit V. MELD-Na score and postoperative complications in hernia repair. Hernia. 2019 Aug;23(4):823. doi: 10.1007/s10029-019-01886-z. Epub 2019 Jan 22. No abstract available.
PubMed 30671898
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of MELD-Na Score for Perioperative Complications in Non-cirrhotic Patients With Gastric Cancer
- ClinicalTrials.gov ID
- NCT04791293
- Acronym / sponsor ID
- 2630
- Conditions
- Gastric Cancer, Complication,Postoperative, Complications; Gastrointestinal, Postoperative, Morality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 5 Aug 2022 (actual)
- Study completion
- 5 Aug 2022 (actual)
- First posted
- 10 Mar 2021 (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.
Gastric cancer is the fifth most common cancer worldwide. Gastrectomy with lymphadenectomy is still the most effective treatment modality, depending on the stage and location. Despite many radiological, surgical and anesthetic innovations, serious complications such as anastomotic leakage, intra-abdominal abscesses, wound complications are seen secondary to gastrectomy. Many clinical studies have been conducted to prevent and predict these complications.
The Model for End-Stage Liver Disease (MELD) score, in which bilirubin, international normalized ratio (INR) and serum creatinine values were used to determine surgical risks in patients scheduled for liver transplantation. Latter developed by adding serum sodium (Na) to the formula. The MELD-Na score is used to predict postoperative complications in non-cirrhotic patients because of its simple and easy calculation.Moreover, The Meld-Na score was later used to predict complications for surgical procedures other than liver surgery such as colorectal surgery.
In this study, we aimed to investigate the importance of the Meld-Na score in predicting the perioperative and postoperative outcomes in patients with gastric cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: MELD-Na scorePatients with postoperative complications |
| Group 2 | – | Other: MELD-Na scorePatients without postoperative complications |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing gastrectomy due to gastric cancer
Key inclusion criteria (1 listed)
- Patients undergoing gastrectomy due to gastric cancer
Key exclusion criteria (3 listed)
- Patients with pulmonary, hepatic and renal disfunctions,
- Patients with diagnosed with a different cancer in the last 5 years and
- Pregnant patients
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 |
|---|---|---|
| MELD-Na scoreMELD-Na scores will be compared between the groups | Other | Group 1, Group 2 |
Primary outcome
MELD-Na score difference between the groups
Time frame: 30 days
Importance of MELD-Na score in predicting postoperative complications in patients with gastric cancer
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 9 Aug 2022.
- Background: PubMed 30463752Coakley KM, Sarasani S, Prasad T, Steele SR, Paquette I, Heniford BT, Davis BR. MELD-Na Score as a Predictor of Anastomotic Leak in Elective Colorectal Surgery. J Surg Res. 2018 Dec;232:43-48. doi: 10.1016/j.jss.2018.04.012. Epub 2018 Jul 2.
- Background: PubMed 30446849Schlosser KA, Kao AM, Zhang Y, Prasad T, Kasten KR, Davis BR, Heniford BT, Colavita PD. MELD-Na score associated with postoperative complications in hernia repair in non-cirrhotic patients. Hernia. 2019 Feb;23(1):51-59. doi: 10.1007/s10029-018-1849-2. Epub 2018 Nov 16.
- Background: PubMed 30671898Yasri S, Wiwanitkit V. MELD-Na score and postoperative complications in hernia repair. Hernia. 2019 Aug;23(4):823. doi: 10.1007/s10029-019-01886-z. Epub 2019 Jan 22. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Cihad Tatar, MD principal investigator
Istanbul Training and Research 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 and Complication,Postoperative, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
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 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: finished, as of the sponsor's last update on 9 Aug 2022. 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 Turkey (Türkiye). 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?
MELD-Na score difference between the groups (time frame: 30 days). 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 NCT04791293, which also lists 3 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 9 Aug 2022.