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NCT Number: NCT07309991

Postoperative Hypoxemia Increases the Risk of Anastomotic Leak After Radical Esophagectomy

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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%.

Study contacts

Contact information is provided by the study sponsor or research team.

Hong Yang, M.D.

CONTACT

[email protected]

8613560405144

Yizhang Chen, M.D. candidate

CONTACT

[email protected]

8613533718832

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • Affiliated Cancer Hospital of Shantou University Medical College
  • Affiliated Hospital of North Sichuan Medical College
  • Hebei Medical University Fourth Hospital
  • Shanghai Chest Hospital
  • Sichuan Cancer Hospital and Research Institute

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Dec 30, 2025
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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