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

NCT07309991 | Completed

• 1 other identifier: B2025-825-01
• Study Type: observational
• Target: 2,083
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Carcinoma; Esophageal Adenocarcinoma; Esophagectomy; PaO2; Esophageal Anastomotic Leakeage

Keywords

Effect of Postoperative PaO₂ on Anastomotic Leakage Following Esophagectomy

Outcome Measures

Primary Outcomes (1)

• Esophageal Anastomotic Leakage Rate

  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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Adenocarcinoma Of Esophagus

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Hong Yang, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 30, 2025
• Study Start: January 1, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

CN (1)