Postoperative Hypoxemia Increases the Risk of Anastomotic Leak After Radical Esophagectomy

NCT07309991 | Recruiting

• 1 other identifier: B2025-825-01
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 6

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.

Conditions

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

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 qualify if:

• 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

You may not qualify if:

• Patients who did not require esophageal reconstruction
• Patients undergoing esophageal replacement with colon
• Patients with incomplete data

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Sichuan Cancer Hospital and Research Institute: collaborator
• Affiliated Hospital of North Sichuan Medical College: collaborator
• Hebei Medical University Fourth Hospital: collaborator
• Affiliated Cancer Hospital of Shantou University Medical College: collaborator
• Shanghai Chest Hospital: collaborator

Study Sites (6)

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

Guangzhou, Guangdong, 510060, China

RECRUITING

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, China

RECRUITING

The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital

Shijiazhuang, Hebei, China

RECRUITING

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Sichuan Cancer Hospital

Chengdu, Sichuan, China

RECRUITING

0817-2598459

Nanchong, Sichuan, China

RECRUITING

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

Central Study Contacts

Hong Yang, M.D.

CONTACT

8613560405144; yanghong@sysucc.org.cn

Yizhang Chen, M.D. candidate

CONTACT

8613533718832; chenyizhang@sysucc.org.cn

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 (Estimated): December 1, 2026
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

CN (6)