Outcomes of Laparoscopic Gastrectomy

• Conditions: Gastric Cancer; Laparoscopic Gastrectomy

• Registration Number: NCT04652986
• Lead Sponsor: Juan Carlos Martín del Olmo

Brief Summary

A prospective study of the results of laparoscopic approach of gastric carcinoma in western patients is designed. The working hypothesis proposes obtaining similar results to those obtained in the series reported by eastern hospitals (Japan and Korea) and, at least, equivalent to those recorded in conventional surgery.

Detailed Description

This is a single-center prospective study. All gastric adenocarcinoma patients operated on between January 2004 and December 2022 who underwent laparoscopic resection with D1-D2 lymphadenectomy were considered.

The exclusion criteria were patients who were lost to follow-up, were unfit for surgery, underwent palliative surgery or had T4b lesions or gastric neoplasms other than adenocarcinoma.

The preoperative evaluation included laboratory tests, upper digestive endoscopy with biopsy, computed tomography scans (chest, abdomen, and pelvis), and endoscopic ultrasound in selected cases.

The tumor node, metastasis (TNM) protocol of the College of American Pathologists was used for staging In the preoperative workup, the patients were classified according to the American Anesthesiology Association (ASA).

Perioperative and postoperative complications will be classified according to the Clavien-Dindo system.

Length of hospital stay, age, sex, comorbidities, extent of surgery, pTNM stage, and disease-free survival (DFS) will be analyzed.

The followed-up it is planned at one, three and six months after surgery and every 6 months later until the fifth year, then once a year.

Statistical analyses were performed using SPSS, ver. 25.0 (SPSS Inc., Chicago IL, USA). The demographics, perioperative data, operation details, length of hospital stay, morbidity, mortality and pathologic and oncological outcomes are expressed as numbers and percentages for qualitative variables and medians and interquartile ranges (IQRs) for quantitative variables.

Factors associated with recurrence risk at 12, 36 and 60 months will be evaluated using univariate and multivariate Cox regression analyses. Variables with P \< 0.1 in the univariate analysis were further introduced into the multivariate analysis using the Wald selection method. TNM stage will be analyzed for its impact on DFS using the Kaplan-Meier method and the log-rank test at 12, 36 and 60 months.

To determine the risk factors for the development of serious morbidity (Clavien-Dindo ≥III), we first performed univariate and multivariate logistic regression analyses. Variables with P\<0.1 in the univariate analysis will be further introduced into the multivariate analysis with the Wald selection method. P values \< 0.05 were considered statistically significant.

This study involved the use of data from clinical records. To guarantee the proper handling of the information, the data were treated confidentially and anonymously according to the provisions of the Spanish Organic Law 15/1999, of 13 December 1999, on Personal Data Protection (LOPD). All methods were performed in accordance with the guidelines and regulations established by the Declaration of Helsinki (1964, revised in 1983) on biomedical research in humans, the Spanish Royal Decree 1090/2015, of December 4, which regulates clinical trials with drugs, the Research Ethics Committees with drugs and the Spanish Registry of Clinical Studies.

Ethical approval from the Clinical Trials and Ethics Committee of Valladolid University was granted.

Study Timeline

• Study Start: 2004-01
• Status Verified: 2020-11
• Primary Completion: 2020-11
• Study First Submitted: 2020-11-18
• Study First Submitted QC: 2020-11-25
• Last Update Submitted: 2020-11-25
• Study First Posted: 2020-12-04
• Last Update Posted: 2020-12-04
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients diagnosed of gastric adenocarcinoma fit for surgical treatment.

Exclusion Criteria

• patients who were lost to follow-up
• patients unfit for surgery
• palliative surgery
• T4b lesions
• neoplasms other than adenocarcinoma

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-free survival at three years	Three years.	Rate of patients who reach this condition
Disease-free survival at five years	Five years	Rate of patients who reach this condition

Secondary Outcome Measures

Name	Time	Method
Three years overall survival	Three years.	Rate of patients who reach this condition
Five years overall survival	Five years	Rate of patients who reach this condition

Trial Locations

Locations (1)

Juan Carlos Martín del Olmo; 🇪🇸 Medina Del Campo, Valladolid, Spain