Postoperative Low Oxygen and Chance of Leaks After Esophageal Surgery
Official title: Postoperative Hypoxemia Increases the Risk of Anastomotic Leak After Radical Esophagectomy
Run by Sun Yat-sen University · NCT07309991 · Data updated 2026-11-12
This study looks at whether low oxygen levels after esophageal cancer surgery increase the chance of an anastomotic leak.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 2500 (estimated) |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 6 sites (Guangzhou, Guangdong and 5 other locations) |
| Status | Recruiting |
| Started | January 1, 2021 |
| Main results expected | December 1, 2025 |
| Study ends | December 1, 2026 |
| Registry record updated | June 16, 2026 |
| Trial ID | NCT07309991 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with esophageal carcinoma undergoing radical esophagectomy, who had postoperative ABG data and at least one post-op imaging or endoscopy for the anastomosis.
✕Probably not a fit
Patients without documented postoperative hypoxemia or without reconstructed esophagus may derive no demonstrated benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational analysis reviews cases from the past five years to see if postoperative hypoxemia (PaO2 < 80 mmHg) is linked to higher rates of esophageal anastomotic leakage. Patients are categorized by whether they had at least one PaO2 reading below 80 mmHg within the first week after surgery, and leakage rates are compared between groups. The study also explores if correcting hypoxemia could reduce leakage risk, using diagnostic methods such as barium swallow, endoscopy, and imaging to confirm leaks. The goal is to determine whether postoperative hypoxemia is an independent and potentially modifiable risk factor. Findings may inform postoperative care and oxygen management after radical esophagectomy.
Why it matters
Potential benefit: If hypoxemia is linked to leaks and is modifiable, adjusting oxygen therapy postoperatively could reduce leak risk and improve recovery.
How similar studies have gone: Previous work has suggested a relationship between postoperative oxygen levels and surgical site complications in thoracic surgery, but this specific association in esophagectomy remains variably demonstrated.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Department of Thoracic Surgery, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 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
Study contacts
- Principal investigator: Hong Yang, M.D. — Department of Thoracic Surgery, Sun Yat-sen University Cancer Center
- Study coordinator: Hong Yang, M.D.
- Email: yanghong@sysucc.org.cn
- Phone: 8613560405144
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.