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Recruiting NCT07309991

Postoperative Hypoxemia Increases the Risk of Anastomotic Leak After Radical Esophagectomy

— Observational Esophageal Carcinoma Esophageal Adenocarcinoma Esophagectomy PaO2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Esophageal Carcinoma, Esophageal Adenocarcinoma, Esophagectomy, PaO2. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This study aims to determine whether postoperative hypoxia (arterial partial pressure of oxygen (PaO₂)\<80 mmHg) is an independent risk factor for anastomotic leakage after esophagectomy. The investigators conducted a retrospective analysis of cases from their center over the past five years, stratifying patients into Low Pa0₂ Group and Normal Pa0₂ Group based on postoperative oxygen levels and comparing the incidence of anastomotic leakage between the groups. The goal is to establish whether hypoxia is a causative risk factor and whether correcting it can reduce the risk of anastomotic leakage.

Detailed description

This retrospective study included all patients who underwent radical esophagectomy at our center over the past five years. After screening based on inclusion and exclusion criteria, PaO₂ levels within the first postoperative week were recorded (the lowest value was used if multiple measurements were taken on the same day), along with whether the condition improved after corrective interventions, patients were accordingly divided into Low Pa0₂ Group (at least one recorded instance of PaO₂ \<80 mmHg) and Normal Pa0₂ Group. Anastomotic leakage was diagnosed based on barium swallow, endoscopy, chest-abdominal CT, or typical clinical signs. By comparing the incidence of anastomotic leakage between the two groups, the relationship between postoperative PaO₂ and anastomotic leakage was analyzed, with further investigation into whether postoperative hypoxemia constitutes an independent and modifiable risk factor.

Primary outcome measures

  • Esophageal Anastomotic Leakage Rate [Time frame: From the date of surgery to 30 days postoperatively]

Eligibility criteria

Inclusion criteria

  • Patients diagnosed with esophageal carcinoma or benign esophageal tumors
  • Patients requiring surgical resection of the lesion with subsequent esophageal reconstruction
  • Patients must have had at least one postoperative arterial blood gas analysis
  • Patients must have routinely undergone at least one of the following for postoperative evaluation of the anastomosis: endoscopy, CT scan, or esophagram

Exclusion criteria

  • Patients who did not require esophageal reconstruction
  • Patients undergoing esophageal replacement with colon
  • Patients with incomplete data

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 6 centers
  • Department of Thoracic Surgery, Sun Yat-sen University Cancer Center — Guangzhou
  • Cancer Hospital of Shantou University Medical College — Shantou
  • The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital — Shijiazhuang
  • Shanghai Chest Hospital — Shanghai
  • Sichuan Cancer Hospital — Chengdu
  • 0817-2598459 — Nanchong

Identifiers

NCT: NCT07309991 · B2025-825-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗