Esophageal CarcinomaNCT07309991
Postoperative Hypoxemia Increases the Risk of Anastomotic Leak After Radical Esophagectomy
An observational study of Esophageal Carcinoma and Esophageal Adenocarcinoma, run by Sun Yat-sen University at 6 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Carcinoma, Esophageal Adenocarcinoma, Esophagectomy
- How many people
- 2,500 participants
- Where
- 6 sitesChina
- Study dates
- 1 Jan 2021to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients who did not require esophageal reconstruction
- Patients undergoing esophageal replacement with colon
- Patients with incomplete data
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Sichuan Cancer Hospital
Chengdu, Sichuan
Xuefeng Leng, MD, 028 8542 0305, leng724@163.com
- Recruiting
Department of Thoracic Surgery, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Hong Yang, M.D., 8613560405144, yanghong@sysucc.org.cn
- Recruiting
0817-2598459
Nanchong, Sichuan
Hao Yang, MD, 501912904@qq.com
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality
Zhigang Li, MD, 021-22200000, zhigang.li@shsmu.edu.cn
- Recruiting
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong
Shaobin Li, MD, 0754 8855 5844, chensb535176@hotmail.com
- Recruiting
The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital
Shijiazhuang, Hebei
Xinjian Xu, MD, 0311-86095588, syxuxinjian0799@hebmu.edu.cn
About this study
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.
Read the 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.
- Conditions
- Esophageal Carcinoma, Esophageal Adenocarcinoma, Esophagectomy, PaO2, Esophageal Anastomotic Leakeage
- Keywords
- Effect of Postoperative PaO₂ on Anastomotic Leakage Following Esophagectomy
- Medical subject headings
- Esophageal Neoplasms, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: From the date of surgery to 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start1 Jan 2021
- Primary completion1 Dec 2025
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Sichuan Cancer Hospital and Research Institute, Affiliated Hospital of North Sichuan Medical College, Hebei Medical University Fourth Hospital, Affiliated Cancer Hospital of Shantou University Medical College, Shanghai Chest Hospital
- Responsible party
- Principal investigator, Yang Hong, Sun Yat-sen University
- Investigators
- Hong Yang, M.D., Principal investigator, Department of Thoracic Surgery, Sun Yat-sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309991
- Sponsor's protocol ID
- B2025-825-01
- Status last verified
- Jun 2026
- First submitted
- 16 Dec 2025
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Hypoxemia Increases the Risk of Anastomotic Leak After Radical Esophagectomy
- ClinicalTrials.gov ID
- NCT07309991
- Acronym / sponsor ID
- B2025-825-01
- Conditions
- Esophageal Carcinoma, Esophageal Adenocarcinoma, Esophagectomy, PaO2, Esophageal Anastomotic Leakeage
- Keywords
- Effect of Postoperative PaO₂ on Anastomotic Leakage Following Esophagectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Sichuan Cancer Hospital and Research Institute, Affiliated Hospital of North Sichuan Medical College, Hebei Medical University Fourth Hospital, Affiliated Cancer Hospital of Shantou University Medical College, Shanghai Chest Hospital
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients who did not require esophageal reconstruction
- Patients undergoing esophageal replacement with colon
- Patients with incomplete data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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%.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hong Yang, M.D. principal investigator
Department of Thoracic Surgery, Sun Yat-sen University Cancer Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Carcinoma and Esophageal Adenocarcinoma, run by Sun Yat-sen University at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong Yang, M.D. (8613560405144, yanghong@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esophageal Anastomotic Leakage Rate (time frame: From the date of surgery to 30 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.