Outcomes of Laparoscopic Gastrectomy

November 25, 2020 updated by: Juan Carlos Martín del Olmo

Mid- and Long-term Surgical and Oncological Outcomes of Total Laparoscopic Gastrectomy for Gastric Cancer: A Prospective Study

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Valladolid
      • Medina Del Campo, Valladolid, Spain, 47400
        • Recruiting
        • Juan Carlos Martín del Olmo
        • Contact:
          • Juan Carlos Martín del Olmo, MD,PhD
          • Phone Number: +34 629646199
          • Email: jcmolmo@gmail.com
        • Sub-Investigator:
          • Juan Ramón Gómez López, MD,PhD
        • Sub-Investigator:
          • Pilar Concejo Cutoli, MD,PhD
        • Sub-Investigator:
          • M. Luz Martín Esteban, MD,PhD
        • Sub-Investigator:
          • Cristina López Mestanza, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed of gastric adenocarcinoma in the area care of Medina del Campo Hospital.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival at three years
Time Frame: Three years.
Rate of patients who reach this condition
Three years.
Disease-free survival at five years
Time Frame: Five years
Rate of patients who reach this condition
Five years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Three years overall survival
Time Frame: Three years.
Rate of patients who reach this condition
Three years.
Five years overall survival
Time Frame: Five years
Rate of patients who reach this condition
Five years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative mortality
Time Frame: One month
Rate of patients died in the first thirty days
One month
Operative morbidity
Time Frame: One month
Rate of operative complications
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Juan Carlos Martín del Olmo

Investigators

  • Study Director: Juan Carlos Martín del Olmo, MD,PhD, Hospital de Medina del Campo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2004

Primary Completion (Actual)

November 1, 2020

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

November 18, 2020

First Submitted That Met QC Criteria

November 25, 2020

First Posted (Actual)

December 4, 2020

Study Record Updates

Last Update Posted (Actual)

December 4, 2020

Last Update Submitted That Met QC Criteria

November 25, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMCampo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastric Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe