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Postoperative Hypoxemia Increases the Risk of Anastomotic Leak After Radical Esophagectomy

Postoperative Hypoxemia Increases the Risk of Anastomotic Leak After Radical Esophagectomy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07309991
Enrollment
2500
Registered
2025-12-30
Start date
2021-01-01
Completion date
2026-12-01
Last updated
2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Adenocarcinoma, Esophageal Anastomotic Leakeage, Esophageal Carcinoma, Esophagectomy, PaO2

Keywords

Effect of Postoperative PaO₂ on Anastomotic Leakage Following Esophagectomy

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. 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.

Interventions

None listed

Sponsors

Sun Yat-sen University
Lead SponsorOTHER
Sichuan Cancer Hospital and Research Institute
CollaboratorOTHER
Affiliated Hospital of North Sichuan Medical College
CollaboratorOTHER
Hebei Medical University Fourth Hospital
CollaboratorOTHER
Affiliated Cancer Hospital of Shantou University Medical College
CollaboratorOTHER
Shanghai Chest Hospital
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Esophageal Anastomotic Leakage RateFrom the date of surgery to 30 days postoperativelyAnastomotic 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%.

Countries

China

Contacts

CONTACTHong Yang, M.D.
yanghong@sysucc.org.cn8613560405144
CONTACTYizhang Chen, M.D. candidate
chenyizhang@sysucc.org.cn8613533718832
PRINCIPAL_INVESTIGATORHong Yang, M.D.

Department of Thoracic Surgery, Sun Yat-sen University Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026