Postoperative Hypoxemia Increases the Risk of Anastomotic Leak After Radical Esophagectomy

June 13, 2026 updated by: Yang Hong, Sun Yat-sen University
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Department of Thoracic Surgery, Sun Yat-sen University Cancer Center
        • Contact:
      • Shantou, Guangdong, China
        • Recruiting
        • Cancer Hospital of Shantou University Medical College
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China
        • Recruiting
        • The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Shanghai Chest Hospital
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • Sichuan Cancer Hospital
        • Contact:
      • Nanchong, Sichuan, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This retrospective cohort study included patients diagnosed with esophageal carcinoma or benign esophageal tumors who required surgical resection of the lesion followed by esophageal reconstruction. All patients had at least one postoperative arterial blood gas analysis, and anastomotic healing was assessed via esophagram, CT scan, endoscopy, or typical clinical sign.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Low Pa02 Group
Patients were defined as belonging to the Low PaO₂ group if they exhibited at least one recorded instance of PaO₂ <80 mmHg within the first postoperative week.
Normal PaO2 Group
Patients maintained a PaO₂ ≥80 mmHg throughout the first postoperative week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
From the date of surgery to 30 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

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

Investigators

  • Principal Investigator: Hong Yang, M.D., Department of Thoracic Surgery, Sun Yat-sen University Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 16, 2025

First Submitted That Met QC Criteria

December 16, 2025

First Posted (Actual)

December 30, 2025

Study Record Updates

Last Update Posted (Actual)

June 16, 2026

Last Update Submitted That Met QC Criteria

June 13, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2025-825-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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