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Clinical Trials/NCT07309991
NCT07309991
Completed
Not Applicable

Impact of Arterial Partial Pressure of Oxygen on Anastomotic Leakage After Esophagectomy

Sun Yat-sen University1 site in 1 country2,083 target enrollmentStarted: January 1, 2021Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Sun Yat-sen University
Enrollment
2,083
Locations
1
Primary Endpoint
Esophageal Anastomotic Leakage Rate

Overview

Brief Summary

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. We conducted a retrospective analysis of cases from our 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • The inclusion criteria required patients diagnosed with esophageal carcinoma or benign esophageal tumors and requiring surgical resection of the lesion with subsequent esophageal reconstruction. Additionally, patients must have had at least one postoperative arterial blood gas analysis and routinely undergone either endoscopy, CT scan, or esophagram for postoperative evaluation of the anastomosis.

Exclusion Criteria

  • We excluded patients who did not require esophageal reconstruction, those undergoing esophageal replacement with colon, and those with incomplete data.

Outcomes

Primary Outcomes

Esophageal Anastomotic Leakage Rate

Time Frame: From the date of surgery to 30 days postoperatively

Anastomotic leak was confirmed by either barium swallow study, CT scan, or endoscopy, or was clinically considered in cases with obvious salivary secretion from the cervical anastomosis. The esophageal anastomotic leakage rate was calculated as (the number of patients with a confirmed anastomotic leakage / the total number of patients who underwent esophagectomy) × 100%.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Sun Yat-sen University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yang Hong

Professor

Sun Yat-sen University

Study Sites (1)

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