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Specialization in Gastric Cancer Surgery

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ClinicalTrials.gov Identifier: NCT05280665
Recruitment Status : Recruiting
First Posted : March 15, 2022
Last Update Posted : March 15, 2022
Sponsor:
Information provided by (Responsible Party):
Ali GUNER, Karadeniz Technical University

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment
Stomach Neoplasms Gastric Cancer Other: Specialization

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
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Study Type : Observational
Estimated Enrollment : 274 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Impact of Specialization on Clinical Outcomes in Gastric Cancer Surgery
Actual Study Start Date : February 14, 2022
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
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 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
 Other: Specialization
  • 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 Name: Gastric cancer surgery


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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) ]
    Death from any cause within 90 days after surgery or at any time if not discharged from hospital

  2. Postoperative complication rate [ Time Frame: Within 30 days after the operation ]
    Any complications (graded by the Clavien-Dindo classification) occurred in the postoperative period

  3. Postoperative major complication rate [ Time Frame: Within 30 days after the operation ]
    ≥grade-III Clavien-Dindo complications occurred in the postoperative period

  4. Readmission [ Time Frame: Within 30 days after the operation ]
    Readmission requiring re-hospitalization for any complications after discharge

  5. 3-year overall survival [ Time Frame: 3 years after surgery ]
    Death from any cause is defined as an event.

  6. 3-year recurrence-free survival [ Time Frame: 3 years after surgery ]
    Death from any cause or the recurrence of gastric cancer are an event.

  7. Hospital stay [ Time Frame: From the date of surgery until the date of hospital discharge, assessed up to 90 days after the operation ]
    Duration of postoperative hospital stays


Other Outcome Measures:
  1. Failure-to-cure [ Time Frame: Within 30 days after the operation ]
    futile surgery due to intraoperative distant metastasis/irresectability, OR microscopically or macroscopically incomplete resection OR 30-day mortality

  2. Neoadjuvant treatment usage [ Time Frame: Within the three months before surgery ]
    Neoadjuvant treatment usage rates in patients undergoing surgical treatment


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with clinical stage 1-3 gastric adenocarcinoma undergoing surgical treatment for curative purposes
Criteria

Inclusion Criteria:

  • cStage I/II/III gastric cancer
  • Histologically proven gastric adenocarcinoma
  • Underwent surgery with curative intent

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05280665


Contacts
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Contact: Ali Guner, MD +90 (462) 377 54 39 draliguner@yahoo.com

Locations
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Turkey
Karadeniz Technical University, Faculty of Medicine, Farabi Hospital Recruiting
Trabzon, Turkey, 61080
Contact: Ali GUNER, MD    ‭+90 (462) 377 54 39‬    draliguner@yahoo.com   
Contact: Murat E Reis, MD    ‭+90 (534) 648 43 51‬    memreis61@gmail.com   
Sponsors and Collaborators
Karadeniz Technical University
Investigators
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Principal Investigator: Ali Guner, MD Karadeniz Technical University Faculty of Medicine
More Information
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Publications:

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Responsible Party: Ali GUNER, Professor, MD, Karadeniz Technical University
ClinicalTrials.gov Identifier: NCT05280665    
Other Study ID Numbers: GastCaSpec
First Posted: March 15, 2022    Key Record Dates
Last Update Posted: March 15, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: With a reasonable request, we are open to share IPD.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ali GUNER, Karadeniz Technical University:
Specialization
Postoperative Complications
Morbidity
Gastrectomy
Gastric Cancer
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases