Clinical trial NCT03909997: Severe Complications After Gastrectomy for Esophagogastric Junction and Gastric Cancer
Official title: Severe Complications After Gastrectomy for Esophagogastric Junction and Gastric Cancer: Perioperative Results and Long Term Survival
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
Esophagogastric Junction Disorder
Keywords: Stomach neoplasms
gastrectomy
Risk factors
morbidity
adenocarcinoma
Lead sponsor: Hospital Dr Sotero del Rio
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Histology different from adenocarcinoma.

Primary outcomes:
measure: Number of patients with severe 30-day or in-hospital morbidity
timeFrame: Perioperative
Secondary outcomes:
measure: Median and percentage of patients with long-term survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Sotero del Rio
state: RM
Study officials:
affiliation: Hospital Sotero Del Rio
name: Enrique M Norero, MD
role: PRINCIPAL_INVESTIGATOR
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