Stomach NeoplasmsNCT05280665
Specialization in Gastric Cancer Surgery
An observational study of Stomach Neoplasms and Gastric Cancer, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
Specialization is having competent and effective knowledge on a subject, and the tendency towards specialization is increasing due to the fact that it increases the success in the follow-up and treatment process of diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Neoplasms, Gastric Cancer
- What is being tested?
- Specialization
- How many people
- 537 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Feb 2022to 1 Mar 2023
- 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 clinical stage 1-3 gastric adenocarcinoma undergoing surgical treatment for curative purposes
Who may be able to join
- cStage I/II/III gastric cancer
- Histologically proven gastric adenocarcinoma
- Underwent surgery with curative intent
Who cannot join
- Under 18 years old
- Patients with non-adenocarcinoma diagnosis
- Emergency surgeries
- The need for a thoracic approach
- Patients with a history of non-gastric cancer
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karadeniz Technical University, Faculty of Medicine, Farabi Hospital
Trabzon, 61080
About this study
Official title: The Impact of Specialization on Clinical Outcomes in Gastric Cancer Surgery
Specialization is having competent and effective knowledge on a subject, and the tendency towards specialization is increasing due to the fact that it increases the success in the follow-up and treatment process of diseases. It has been observed that specialization in cancer surgery provides significant improvement in clinical outcomes in recent years. In this study, the effect of specialization in gastric cancer surgery on clinical outcomes is being investigated.
Read the detailed description
Specialization is having sufficient and effective knowledge on a subject. Today, in the medical world, specialization is defined as having competent knowledge on a disease, and in recent years, the benefit of specialization has begun to be emphasized. Initially, it was defined as a branching and over the years, internal and surgical departments were divided into sub-areas. In surgical sciences, these fields are determined as traumatology, breast-endocrine surgery and gastrointestinal system surgery. This branching has brought a different perspective and approach to diseases and has made it possible to be more effective in the management of diseases. In recent years, a specialization approach on diseases and organ systems has developed within these branches. In surgery, surgeons specialized on many organs such as pancreatic surgery, colorectal surgery, gastric surgery, breast surgery, ovarian surgery have increased the efficiency in the management of diseases and the survival and disease-free survival rates of the patients have increased, and the postoperative morbidity and mortality rates have decreased.
Gastric cancer is one of the most common malignant cancers. It is the fifth most common cause of cancer-related death worldwide. Despite advances in diagnosis and treatment methods, patients may still be diagnosed late, and patients still have a poor prognosis due to the biology of gastric cancer. Even in properly treated patients, five-year survival rates are around 20-30%. With the development of surgical techniques and disease management, clinical outcomes of the disease have improved and mortality has been reduced. In the studies, the definition of gastric surgeon was created and it was determined that the mortality decreased proportionally with the increase in the patient volume of the surgeon. In gastric cancer surgery, there are mostly studies on the number of surgeon patients and the number of hospital patients. Post-hoc analysis of hospital volume on patients included in the CRITICS study showed a 13.1% increase in survival in high-volume hospitals compared to low-volume hospitals. The number of annual resections ≥21 was determined as the definition of high-volume hospital. In addition, it was determined that there was a decrease in mortality as the number of annual cases increased in high-volume hospitals. In another study, it was seen that there was an improvement in the mortality of medium and high volume hospitals compared to low volume hospitals. The majority of studies in gastric cancer surgery have focused on hospital volume and surgeon volume. There are no data on the specialization of the surgeon other than a study based in Japan.
In this study, it was aimed to evaluate the effect of specialization in gastric cancer surgery on short- and long-term clinical outcomes.
- Conditions
- Stomach Neoplasms, Gastric Cancer
- Being tested
- Specialization
- Keywords
- Specialization, Postoperative Complications, Morbidity, Gastrectomy, Gastric Cancer
- 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.
SpecializationOther
Also called Gastric cancer surgery
- Who had undergone professional training in gastric cancer surgery in specialized gastric cancer centers (in Japan or Korea),
- Who identified themselves as primarily gastric surgeons during the study period
- Whose annual gastric cancer surgery volume is more than 21
| Study group | Role | What they receive |
|---|---|---|
| The non-specialized group | Patients who were operated by a non-specialized surgeon. Non-specialized surgeons were defined as general surgeon who does not have the characteristics of a specialized gastric cancer surgeon. The non-specialized group will be divided into two subgroups (high-volume vs low-volume) for further analysis. | |
| The specialized group | Patients who were operated by a specialized gastric cancer surgeon. Specialized gastric cancer surgeons were defined as surgeons who meet all of the criteria for a specialized gastric cancer surgeon.
* Who had undergone professional training in gastric cancer surgery in specialized gastric cancer centers (in Japan or Korea),
* Who identified themselves as primarily gastric surgeons during the study period
* Whose annual gastric cancer surgery volume is more than 21 Receives: Other: Specialization |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality
Death from any cause within 30 days after surgery or at any time if not discharged from hospital
Measured: 30 days after the operation (postoperative hospital stay ≤ 30 days) or operation to first discharge from hospital (postoperative hospital stay > 30 days)
Secondary outcomes (7)
90-day mortality
Death from any cause within 90 days after surgery or at any time if not discharged from hospital
Measured: 90 days after the operation (postoperative hospital stay ≤ 90 days) or operation to first discharge from hospital (postoperative hospital stay > 90 days)
Postoperative complication rate
Any complications (graded by the Clavien-Dindo classification) occurred in the postoperative period
Measured: Within 30 days after the operation
Postoperative major complication rate
≥grade-III Clavien-Dindo complications occurred in the postoperative period
Measured: Within 30 days after the operation
Readmission
Readmission requiring re-hospitalization for any complications after discharge
Measured: Within 30 days after the operation
3-year overall survival
Death from any cause is defined as an event.
Measured: 3 years after surgery
3-year recurrence-free survival
Death from any cause or the recurrence of gastric cancer are an event.
Measured: 3 years after surgery
Hospital stay
Duration of postoperative hospital stays
Measured: From the date of surgery until the date of hospital discharge, assessed up to 90 days after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start14 Feb 2022
- Primary completion15 Sep 2022
- Study completion1 Mar 2023
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 Stomach NeoplasmsStudies 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
- 537 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali GUNER, Karadeniz Technical University
- Investigators
- Ali Guner, MD, Principal investigator, Karadeniz Technical University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280665
- Sponsor's protocol ID
- GastCaSpec
- Status last verified
- Mar 2023
- First submitted
- 22 Feb 2022
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: With a reasonable request, we are open to share IPD.
Publications
Liang Y, Wu L, Wang X, Ding X, Liang H. The positive impact of surgeon specialization on survival for gastric cancer patients after surgery with curative intent. Gastric Cancer. 2015 Oct;18(4):859-67. doi: 10.1007/s10120-014-0436-1. Epub 2014 Oct 15.
PubMed 25315086Bachmann MO, Alderson D, Edwards D, Wotton S, Bedford C, Peters TJ, Harvey IM. Cohort study in South and West England of the influence of specialization on the management and outcome of patients with oesophageal and gastric cancers. Br J Surg. 2002 Jul;89(7):914-22. doi: 10.1046/j.1365-2168.2002.02135.x.
PubMed 12081743Claassen YHM, van Amelsfoort RM, Hartgrink HH, Dikken JL, de Steur WO, van Sandick JW, van Grieken NCT, Cats A, Boot H, Trip AK, Jansen EPM, Kranenbarg EM, Braak JPBM, Putter H, van Berge Henegouwen MI, Verheij M, van de Velde CJH. Effect of Hospital Volume With Respect to Performing Gastric Cancer Resection on Recurrence and Survival: Results From the CRITICS Trial. Ann Surg. 2019 Dec;270(6):1096-1102. doi: 10.1097/SLA.0000000000002940.
PubMed 29995679Callahan MA, Christos PJ, Gold HT, Mushlin AI, Daly JM. Influence of surgical subspecialty training on in-hospital mortality for gastrectomy and colectomy patients. Ann Surg. 2003 Oct;238(4):629-36; discussion 636-9. doi: 10.1097/01.sla.0000089855.96280.4a.
PubMed 14530734
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Specialization on Clinical Outcomes in Gastric Cancer Surgery
- ClinicalTrials.gov ID
- NCT05280665
- Acronym / sponsor ID
- GastCaSpec
- Conditions
- Stomach Neoplasms, Gastric Cancer
- Keywords
- Specialization, Postoperative Complications, Morbidity, Gastrectomy, Gastric Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 537 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 15 Mar 2022 (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.
Specialization is having competent and effective knowledge on a subject, and the tendency towards specialization is increasing due to the fact that it increases the success in the follow-up and treatment process of diseases. It has been observed that specialization in cancer surgery provides significant improvement in clinical outcomes in recent years. In this study, the effect of specialization in gastric cancer surgery on clinical outcomes is being investigated.
Detailed description
Specialization is having sufficient and effective knowledge on a subject. Today, in the medical world, specialization is defined as having competent knowledge on a disease, and in recent years, the benefit of specialization has begun to be emphasized. Initially, it was defined as a branching and over the years, internal and surgical departments were divided into sub-areas. In surgical sciences, these fields are determined as traumatology, breast-endocrine surgery and gastrointestinal system surgery. This branching has brought a different perspective and approach to diseases and has made it possible to be more effective in the management of diseases. In recent years, a specialization approach on diseases and organ systems has developed within these branches. In surgery, surgeons specialized on many organs such as pancreatic surgery, colorectal surgery, gastric surgery, breast surgery, ovarian surgery have increased the efficiency in the management of diseases and the survival and disease-free survival rates of the patients have increased, and the postoperative morbidity and mortality rates have decreased.
Gastric cancer is one of the most common malignant cancers. It is the fifth most common cause of cancer-related death worldwide. Despite advances in diagnosis and treatment methods, patients may still be diagnosed late, and patients still have a poor prognosis due to the biology of gastric cancer. Even in properly treated patients, five-year survival rates are around 20-30%. With the development of surgical techniques and disease management, clinical outcomes of the disease have improved and mortality has been reduced. In the studies, the definition of gastric surgeon was created and it was determined that the mortality decreased proportionally with the increase in the patient volume of the surgeon. In gastric cancer surgery, there are mostly studies on the number of surgeon patients and the number of hospital patients. Post-hoc analysis of hospital volume on patients included in the CRITICS study showed a 13.1% increase in survival in high-volume hospitals compared to low-volume hospitals. The number of annual resections ≥21 was determined as the definition of high-volume hospital. In addition, it was determined that there was a decrease in mortality as the number of annual cases increased in high-volume hospitals. In another study, it was seen that there was an improvement in the mortality of medium and high volume hospitals compared to low volume hospitals. The majority of studies in gastric cancer surgery have focused on hospital volume and surgeon volume. There are no data on the specialization of the surgeon other than a study based in Japan.
In this study, it was aimed to evaluate the effect of specialization in gastric cancer surgery on short- and long-term clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The non-specialized group | – | –Patients who were operated by a non-specialized surgeon. Non-specialized surgeons were defined as general surgeon who does not have the characteristics of a specialized gastric cancer surgeon. The non-specialized group will be divided into two subgroups (high-volume vs low-volume) for further analysis. |
| The specialized group | – | Other: SpecializationPatients who were operated by a specialized gastric cancer surgeon. Specialized gastric cancer surgeons were defined as surgeons who meet all of the criteria for a specialized gastric cancer surgeon. * Who had undergone professional training in gastric cancer surgery in specialized gastric cancer centers (in Japan or Korea), * Who identified themselves as primarily gastric surgeons during the study period * Whose annual gastric cancer surgery volume is more than 21 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinical stage 1-3 gastric adenocarcinoma undergoing surgical treatment for curative purposes
Key inclusion criteria (3 listed)
- cStage I/II/III gastric cancer
- Histologically proven gastric adenocarcinoma
- Underwent surgery with curative intent
Key exclusion criteria (5 listed)
- Under 18 years old
- Patients with non-adenocarcinoma diagnosis
- Emergency surgeries
- The need for a thoracic approach
- Patients with a history of non-gastric cancer
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 |
|---|---|---|
| SpecializationAlso: Gastric cancer surgery* Who had undergone professional training in gastric cancer surgery in specialized gastric cancer centers (in Japan or Korea), * Who identified themselves as primarily gastric surgeons during the study period * Whose annual gastric cancer surgery volume is more than 21 | Other | The specialized group |
Primary outcome
30-day mortality
Time frame: 30 days after the operation (postoperative hospital stay ≤ 30 days) or operation to first discharge from hospital (postoperative hospital stay > 30 days)
Death from any cause within 30 days after surgery or at any time if not discharged from hospital
7 secondary outcomes
90-day mortality
Time frame: 90 days after the operation (postoperative hospital stay ≤ 90 days) or operation to first discharge from hospital (postoperative hospital stay > 90 days)
Postoperative complication rate
Time frame: Within 30 days after the operation
Postoperative major complication rate
Time frame: Within 30 days after the operation
Readmission
Time frame: Within 30 days after the operation
3-year overall survival
Time frame: 3 years after surgery
3-year recurrence-free survival
Time frame: 3 years after surgery
Hospital stay
Time frame: From the date of surgery until the date of hospital discharge, assessed up to 90 days after the operation
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 21 Mar 2023.
- Background: PubMed 25315086Liang Y, Wu L, Wang X, Ding X, Liang H. The positive impact of surgeon specialization on survival for gastric cancer patients after surgery with curative intent. Gastric Cancer. 2015 Oct;18(4):859-67. doi: 10.1007/s10120-014-0436-1. Epub 2014 Oct 15.
- Background: PubMed 12081743Bachmann MO, Alderson D, Edwards D, Wotton S, Bedford C, Peters TJ, Harvey IM. Cohort study in South and West England of the influence of specialization on the management and outcome of patients with oesophageal and gastric cancers. Br J Surg. 2002 Jul;89(7):914-22. doi: 10.1046/j.1365-2168.2002.02135.x.
- Background: PubMed 29995679Claassen YHM, van Amelsfoort RM, Hartgrink HH, Dikken JL, de Steur WO, van Sandick JW, van Grieken NCT, Cats A, Boot H, Trip AK, Jansen EPM, Kranenbarg EM, Braak JPBM, Putter H, van Berge Henegouwen MI, Verheij M, van de Velde CJH. Effect of Hospital Volume With Respect to Performing Gastric Cancer Resection on Recurrence and Survival: Results From the CRITICS Trial. Ann Surg. 2019 Dec;270(6):1096-1102. doi: 10.1097/SLA.0000000000002940.
- Background: PubMed 14530734Callahan MA, Christos PJ, Gold HT, Mushlin AI, Daly JM. Influence of surgical subspecialty training on in-hospital mortality for gastrectomy and colectomy patients. Ann Surg. 2003 Oct;238(4):629-36; discussion 636-9. doi: 10.1097/01.sla.0000089855.96280.4a.
- Individual participant dataSharing planned: Undecided. With a reasonable request, we are open to share IPD.
Related trials for Stomach Neoplasms
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
RecruitingPhase 1
A Study to Evaluate the Safety,Pharmacokinetics,Pharmacodynamics,and Efficacy of TJ037130 in Adult Participants With Advanced Solid Tumors
Solid Tumor, Metastatic Ovary Cancer
RecruitingPhase 2/3
Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial
Advanced Esophageal Adenocarcinoma, Advanced Gastric Adenocarcinoma
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
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.
Ali Guner, MD principal investigator
Karadeniz Technical University Faculty of Medicine
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 Stomach Neoplasms and Gastric Cancer, run by Karadeniz Technical University 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 3 inclusion and 5 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 21 Mar 2023. 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?
30-day mortality (time frame: 30 days after the operation (postoperative hospital stay ≤ 30 days) or operation to first discharge from hospital (postoperative hospital stay > 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 NCT05280665, 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 21 Mar 2023.