Severe Complications After Gastrectomy for Esophagogastric Junction and Gastric Cancer

April 9, 2019 updated by: Hospital Dr Sotero del Rio

Severe Complications After Gastrectomy for Esophagogastric Junction and Gastric Cancer: Perioperative Results and Long Term Survival

Gastrectomy is the main treatment for gastric and Siewert type II-III esophagogastric junction (EGJ) cancer. This surgery is associated with significant morbidity. The aim of the present study is to identify the predictors of postoperative morbidity and to evaluate long term survival according to complications. This is a retrospective cohort study.

Study Overview

Status

Unknown

Conditions

Detailed Description

Gastrectomy is the main treatment for gastric and Siewert type II-III esophagogastric junction (EGJ) cancer. This surgery is associated with significant morbidity. The aim of the present study is to identify the predictors of postoperative morbidity and to evaluate long term survival according to complications.

This was a retrospective cohort study. The investigators included patients treated with gastrectomy for gastric or EGJ cancers at a single center. Severe morbidity was defined as Clavien-Dindo score ≥3.

The following factors are analyzed: age, sex, comorbidity, American Society of Anesthesiologists (ASA) physical status, tobacco and alcohol consumption, body mass index (BMI), hematocrit, serum albumin level, tumor location, the use of preoperative chemotherapy, laparoscopic or open surgery, total or subtotal gastrectomy, duodenal stump closure, multi-organ resection, lymphadenectomy, reconstruction method, T status, lymph node metastasis, and resection margin. The T stage was grouped by T1-T2 and T3-T4 for analysis. Patients will be followed for 5 years after surgery for survival analysis. A multivariate analysis is performed to identify predictors of overall and severe morbidity; and predictors of long-term survival.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Chile
    • RM
      • Santiago, RM, Chile, 7501064
        • Recruiting
        • Hospital Sotero del Rio
        • Contact:

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All consecutive patients treated with a gastrectomy for gastric cancer or esophagogastric cancer at a single center are included.

Description

Inclusion Criteria:

  • Patients treated with a gastrectomy for gastric cancer or esophagogastric cancer.
  • Confirmed adenocarcinoma histology.

Exclusion Criteria:

  • Histology different from 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
Number of patients with severe 30-day or in-hospital morbidity
Time Frame: Perioperative
Clavien 3 or higher complications
Perioperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median and percentage of patients with long-term survival
Time Frame: 5 years
5 year survival
5 years

Collaborators and Investigators

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

Sponsor

Hospital Dr Sotero del Rio

Investigators

  • Principal Investigator: Enrique M Norero, MD, Hospital Sotero del Rio

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)

April 5, 2019

Primary Completion (Anticipated)

April 5, 2021

Study Completion (Anticipated)

April 5, 2022

Study Registration Dates

First Submitted

April 6, 2019

First Submitted That Met QC Criteria

April 9, 2019

First Posted (Actual)

April 10, 2019

Study Record Updates

Last Update Posted (Actual)

April 11, 2019

Last Update Submitted That Met QC Criteria

April 9, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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