Severe Complications After Gastrectomy for Esophagogastric Junction and Gastric Cancer

• Conditions: Gastric Cancer; Esophagogastric Junction Disorder

• Registration Number: NCT03909997
• Lead Sponsor: Hospital Dr Sotero del Rio

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.

Study Timeline

• Status Verified: 2019-04
• Study Start: 2019-04-05
• Study First Submitted: 2019-04-06
• Study First Submitted QC: 2019-04-09
• Last Update Submitted: 2019-04-09
• Study First Posted: 2019-04-10
• Last Update Posted: 2019-04-11
• Primary Completion: 2021-04-05
• Study Completion: 2022-04-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

• Histology different from adenocarcinoma.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with severe 30-day or in-hospital morbidity	Perioperative	Clavien 3 or higher complications

Secondary Outcome Measures

Name	Time	Method
Median and percentage of patients with long-term survival	5 years	5 year survival

Trial Locations

Locations (1)

Hospital Sotero del Rio; 🇨🇱 Santiago, RM, Chile