Minimally-invasive versus open surgery for gastric cancer - cross-sectional analysis
| ISRCTN | ISRCTN53410429 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53410429 |
- Submission date
- 21/08/2023
- Registration date
- 29/08/2023
- Last edited
- 14/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Since gastric (stomach) cancer is one of the most common cancers worldwide, this study aimed to assess the outcomes of the two most common types of surgery among gastric cancer patients: open surgery versus minimally invasive (laparoscopic, robotic) surgery.
Who can participate?
Patients aged 18 years and over with gastric cancer who underwent curative-intent treatment between 2013-2019
What does the study involve?
The study involves the assessment of the optimal method of surgery (open versus minimally invasive) in gastric cancer patients using data collected from the National Cancer Database (NCDB).
What are the possible benefits and risks of participating?
This is an observational study, however, the results of this retrospective data suggest a need for further prospective trials comparing open versus minimally-invasive surgery for gastric cancer.
Where is the study run from?
Medical University of Lublin (Poland)
When is the study starting and how long is it expected to run for?
January 2013 to December 2019
Who is funding the study?
Medical University of Lublin (Poland)
Who is the main contact?
Karol Rawicz-Pruszyński, krpruszynski@gmail.com
Contact information
Scientific
Department of Surgical Oncology
Medical University of Lublin
Radziwiłłowska 13. St
Lublin
20-080
Poland
 ORCID ID |
0000-0002-2555-2114 |
|---|---|
| Phone | +1 (380) 250 81 22 |
| karolrawiczpruszynski@umlub.pl |
Study information
| Study design | Observational cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Improved NCCN guideline compliance and textbook oncological outcomes among patients undergoing minimally invasive surgery for locally advanced gastric cancer – cross-sectional analysis of national cancer database |
| Study objectives | To investigate the rates of National Comprehensive Cancer Network (NCCN) guideline adherence and textbook oncological outcome (TOO) among patients undergoing minimally invasive versus open surgery for gastric cancer |
| Ethics approval(s) | Ethics approval not required |
| Ethics approval additional information | The study was determined to be exempt by the Institutional Review Board of the Ohio State University. The NCDB, a joint quality improvement initiative of the American College of Surgeons Commission on Cancer and the American Cancer Society, is one of the largest cancer registries in the world, comprising over 70% of newly diagnosed cancer cases nationwide. Current NCDB data is available up to 2019 for Higher Education Authorities in the US, including Ohio State University. Since the current study did not change or interfere with available data, there was no need for additional ethics board approval. |
| Health condition(s) or problem(s) studied | Gastric cancer |
| Intervention | In this cross-sectional study patients with stage II/III gastric cancer (cT2-T4N0-3M0) who underwent curative-intent treatment between 2013-2019 were evaluated from National Cancer Database (NCDB). Multivariable analysis was performed to assess the association between surgical approach, NCCN guideline adherence, TOO, and overall survival (OS). |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. National Comprehensive Cancer Network (NCCN) guideline adherence, defined as receipt of stage-specific curative intent treatment (yes/no). For systemic treatment, patients were classified as receiving guideline-adherent care if any perioperative adjunctive therapy (single- or multiagent) was administered (yes/no). For surgical treatment, patients were classified as receiving guideline-adherent care if the primary surgical procedure included evaluation of at least 15 lymph nodes (yes/no), 2. Textbook oncological outcome (TOO) The TOO definition consisted of chemotherapy receipt, (yes/no) adequate gastric resection to achieve negative resection margins (R0) (yes/no), examination of at least 15 lymph nodes (yes/no), followed by no prolonged length of hospital stay (yes/no), no 30-day mortality (yes/no), and no 30-day readmission (yes/no) Data collected from the National Cancer Database (NCDB) for patients with stage II/III gastric cancer (cT2-T4N0-3M0) who underwent curative-intent treatment between 2013-2019 |
| Secondary outcome measures | Overall survival, collected from the National Cancer Database (NCDB) for patients with stage II/III gastric cancer (cT2-T4N0-3M0) who underwent curative-intent treatment between 2013-2019 |
| Overall study start date | 01/01/2013 |
| Completion date | 31/12/2019 |
Eligibility
| Participant type(s) | Population |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 90 Years |
| Sex | Both |
| Target number of participants | 13885 |
| Total final enrolment | 13885 |
| Key inclusion criteria | Patients with stage II/III LAGC (cT2-T4N0-3M0) who underwent curative-intent treatment between 2013 and 2019 evaluated from the National Cancer Database (NCDB) |
| Key exclusion criteria | 1. Did not undergo resection 2. Metastatic (cM1) or early (cT1) GC 3. Underwent palliative care 4. Did not receive or died before planned multimodal treatment 5. Had missing information |
| Date of first enrolment | 01/01/2013 |
| Date of final enrolment | 31/12/2019 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Suite 670
Columbus
43201
United States of America
Sponsor information
University/education
Al. Racławickie 1
Lublin
20-059
Poland
| Phone | +48 (0)81448 5000 |
|---|---|
| monika.ostrowska-kalan@umlub.pl | |
| Website | https://www.umlub.pl |
"ROR" |
https://ror.org/016f61126 |
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- Medical University of Lublin, UML, MUL
- Location
- Poland
Results and Publications
| Intention to publish date | 01/09/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Submission to the International Journal of Surgery |
| IPD sharing plan | The datasets analysed during the current study will be published as a supplement to the results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 31/01/2024 | 14/02/2024 | Yes | No |
Editorial Notes
14/02/2024: Publication reference added.
22/08/2023: Study's existence confirmed by the Institutional Review Board of the Ohio State University.
