Specialization in Gastric Cancer Surgery

Gastric Cancer Clinical Trial

Official title:

The Impact of Specialization on Clinical Outcomes in Gastric Cancer Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05280665
• Other study ID #: GastCaSpec
• Status: Completed
• Start date: February 14, 2022
• Est. completion date: March 1, 2023

Study information

• Verified date: March 2023
• Source: Karadeniz Technical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 537
• Est. completion date: March 1, 2023
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
Turkey	Karadeniz Technical University, Faculty of Medicine, Farabi Hospital	Trabzon

Sponsors (1)

Lead Sponsor	Collaborator
Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Bachmann 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. — View Citation

Callahan 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. — View Citation

Claassen 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Failure-to-cure	futile surgery due to intraoperative distant metastasis/irresectability, OR microscopically or macroscopically incomplete resection OR 30-day mortality	Within 30 days after the operation
Other	Neoadjuvant treatment usage	Neoadjuvant treatment usage rates in patients undergoing surgical treatment	Within the three months before surgery
Primary	30-day mortality	Death from any cause within 30 days after surgery or at any time if not discharged from hospital	30 days after the operation (postoperative hospital stay = 30 days) or operation to first discharge from hospital (postoperative hospital stay > 30 days)
Secondary	90-day mortality	Death from any cause within 90 days after surgery or at any time if not discharged from hospital	90 days after the operation (postoperative hospital stay = 90 days) or operation to first discharge from hospital (postoperative hospital stay > 90 days)
Secondary	Postoperative complication rate	Any complications (graded by the Clavien-Dindo classification) occurred in the postoperative period	Within 30 days after the operation
Secondary	Postoperative major complication rate	=grade-III Clavien-Dindo complications occurred in the postoperative period	Within 30 days after the operation
Secondary	Readmission	Readmission requiring re-hospitalization for any complications after discharge	Within 30 days after the operation
Secondary	3-year overall survival	Death from any cause is defined as an event.	3 years after surgery
Secondary	3-year recurrence-free survival	Death from any cause or the recurrence of gastric cancer are an event.	3 years after surgery
Secondary	Hospital stay	Duration of postoperative hospital stays	From the date of surgery until the date of hospital discharge, assessed up to 90 days after the operation