MedDataX Logo

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

NCT ID: NCT07309991

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2083 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2025-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Esophageal Carcinoma Esophageal Adenocarcinoma Esophagectomy PaO2 Esophageal Anastomotic Leakeage

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Effect of Postoperative PaO₂ on Anastomotic Leakage Following Esophagectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

Normal PaO2 Group

Patients maintained a PaO₂ ≥80 mmHg throughout the first postoperative week.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

* We excluded patients who did not require esophageal reconstruction, those undergoing esophageal replacement with colon, and those with incomplete data.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yang Hong

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hong Yang, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Guangzhou, Guangdong, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B2025-825-01

Identifier Type: -

Identifier Source: org_study_id