Esophageal CancerNCT07043491
Comparison of Endoscopy and Esophagram for the Routine Evaluation of Anastomosis After McKeown Esophagectomy
An observational study of Esophageal Cancer and Surgery-Complications, run by Sun Yat-sen University at 1 site in China.
Trial summary
This retrospective cohort study reviewed patients who underwent McKeown esophagectomy. All patients routinely underwent either endoscopy or esophagram for the evaluation of anastomosis on postoperative day 7. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Surgery-Complications
- What is being tested?
- Endoscopy
- Type of treatment
- Pill or oral medicine
- How many people
- 2 participants
- Where
- 1 siteChina
- Study dates
- 4 Nov 2024to 1 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This retrospective cohort study reviewed patients who underwent McKeown esophagectomy. All patients routinely underwent either endoscopy or esophagram for the evaluation of anastomosis on postoperative day 7.
Who may be able to join
- The inclusion criteria required patients to have routinely undergone either endoscopy or an esophagram for the postoperative evaluation of anastomosis.
Who cannot join
- We excluded the patient with histologically confirmed benign tumors of the esophagus or esophagogastric junction and the patient who had incomplete data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510030
Hong Yang, PhD., 13560405144, yanghong@sysucc.org.cn
About this study
This retrospective cohort study reviewed patients who underwent McKeown esophagectomy. All patients routinely underwent either endoscopy or esophagram for the evaluation of anastomosis on postoperative day 7. The initiation of oral intake depended on the status of anastomosis according to the assessment result of endoscopy or esophagram. All patients were followed up for six months after the assessment of anastomosis.
Read the detailed description
This retrospective cohort study reviewed patients who underwent McKeown esophagectomy. All patients routinely underwent either endoscopy or esophagram for the evaluation of anastomosis on postoperative day 7. The initiation of oral intake depended on the status of anastomosis according to the assessment result of endoscopy or esophagram. The patients whose esophagram indicated an intact anastomosis or whose endoscopy revealed a good healing anastomosis were allowed to initiate oral intake. While the patients whose endoscopy revealed a poor healing anastomosis were monitored with a repeat endoscopy weekly and these patients were delayed for oral intake until the repeat endoscopy revealed a good healing anastomosis. All patients were followed up for six months after the assessment of anastomosis. The primary endpoints were the efficacy of the evaluation of anastomosis, which included the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for AL, the accuracy of the evaluation of anastomosis, and the incidence of AL after oral intake. Cases of AL that were found after the previous assessment were regarded as missed diagnoses when the sensitivity was calculated. The secondary endpoints included the time from surgery to AL diagnosis, the time required for AL healing, and safety profile.
- Conditions
- Esophageal Cancer, Surgery-Complications
- Being tested
- Endoscopy
- Keywords
- Esophageal cancer, Endoscopy, Esophagram, McKeown esophagectomy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoscopyDiagnostic test
We first observed the residual esophagus to evaluate the mucosal color. We then reached the top of the anastomosis to obtain a full view of the anastomosis to exclude obvious leakage around that site. We next conducted a more detailed endoscopic examination at a close focal distance, circumferentially around the anastomosis. During this process, we utilized saline solution to meticulously remove white fibrin coverings and bloodstains to the greatest extent possible to ensure a thorough evaluation of anastomotic integrity. Finally, we inspected the staple line of the tubularized stomach to exclude gastric fistula and assessed the perfusion of the gastric graft. Endoscopic findings were assessed by an additional endoscopist and 3 esophageal surgeons during the examination, as well as by reviewing captured images or videos after endoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopy group | The patients routinely underwent either endoscopy for the evaluation of anastomosis on postoperative day 7. The initiation of oral intake depended on the status of anastomosis according to the assessment result of endoscopy. The patients whose endoscopy revealed a good healing anastomosis were allowed to initiate oral intake. While the patients whose endoscopy revealed a poor healing anastomosis were monitored with a repeat endoscopy weekly and these patients were delayed for oral intake until the repeat endoscopy revealed a good healing anastomosis. Receives: Diagnostic Test: Endoscopy | |
| Esophagram group | All patients routinely underwent esophagram for the evaluation of anastomosis on postoperative day 7. The initiation of oral intake depended on the status of anastomosis according to the assessment result of esophagram. The patients whose esophagram indicated an intact anastomosis were allowed to initiate oral intake. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity for detecting AL
The number of the patients who is true positive for AL/ The total number of AL
Measured: From January 1, 2022 to July 9, 2023
The specificity for detecting AL
The number of the patients who is true negative for AL/ The total number of the patients who did not develop AL
Measured: From January 1, 2022 to July 9, 2023
Predictive positive value for AL
The number of the patients who is true positive for AL/ The number of the patients who is evaluated as AL
Measured: From January 1, 2022 to July 9, 2023
Predictive negative value for AL
The number of the patients who is true negative for AL/ The number of the patients who is determined to have an intact anastomosis
Measured: From January 1, 2022 to July 9, 2023
The incidence of AL after oral intake
The number of the AL that occurs after oral intake/ The number of the patients who were determined to have an intact anastomosis
Measured: From January 1, 2022 to July 9, 2023
Secondary outcomes (2)
The time from surgery to the diagnosis of AL
The time from surgery to the diagnosis of AL
Measured: From January 1, 2022 to July 9, 2023
The time required for the healing of AL
The degree of AL healing was determined on the basis of the evidence that no swallowed liquid flowed out of the anastomosis, accompanied by a repeat examination with a normal result and disappearance of clinical manifestations
Measured: From January 1, 2022 to July 9, 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start4 Nov 2024
- Primary completion9 Jul 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies 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 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Hong, Sun Yat-sen University
- Investigators
- Hong Yang, PhD., Study chair, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043491
- Sponsor's protocol ID
- B2024-656-01
- Status last verified
- Jun 2025
- First submitted
- 2 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It has not yet been determined
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Endoscopy and Esophagram for the Routine Evaluation of Anastomosis After McKeown Esophagectomy
- ClinicalTrials.gov ID
- NCT07043491
- Acronym / sponsor ID
- B2024-656-01
- Conditions
- Esophageal Cancer, Surgery-Complications
- Keywords
- Esophageal cancer, Endoscopy, Esophagram, McKeown esophagectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 9 Jul 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 29 Jun 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 retrospective cohort study reviewed patients who underwent McKeown esophagectomy. All patients routinely underwent either endoscopy or esophagram for the evaluation of anastomosis on postoperative day 7. The initiation of oral intake depended on the status of anastomosis according to the assessment result of endoscopy or esophagram. All patients were followed up for six months after the assessment of anastomosis.
Detailed description
This retrospective cohort study reviewed patients who underwent McKeown esophagectomy. All patients routinely underwent either endoscopy or esophagram for the evaluation of anastomosis on postoperative day 7. The initiation of oral intake depended on the status of anastomosis according to the assessment result of endoscopy or esophagram. The patients whose esophagram indicated an intact anastomosis or whose endoscopy revealed a good healing anastomosis were allowed to initiate oral intake. While the patients whose endoscopy revealed a poor healing anastomosis were monitored with a repeat endoscopy weekly and these patients were delayed for oral intake until the repeat endoscopy revealed a good healing anastomosis. All patients were followed up for six months after the assessment of anastomosis. The primary endpoints were the efficacy of the evaluation of anastomosis, which included the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for AL, the accuracy of the evaluation of anastomosis, and the incidence of AL after oral intake. Cases of AL that were found after the previous assessment were regarded as missed diagnoses when the sensitivity was calculated. The secondary endpoints included the time from surgery to AL diagnosis, the time required for AL healing, and safety profile.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopy group | – | Diagnostic Test: EndoscopyThe patients routinely underwent either endoscopy for the evaluation of anastomosis on postoperative day 7. The initiation of oral intake depended on the status of anastomosis according to the assessment result of endoscopy. The patients whose endoscopy revealed a good healing anastomosis were allowed to initiate oral intake. While the patients whose endoscopy revealed a poor healing anastomosis were monitored with a repeat endoscopy weekly and these patients were delayed for oral intake until the repeat endoscopy revealed a good healing anastomosis. |
| Esophagram group | – | –All patients routinely underwent esophagram for the evaluation of anastomosis on postoperative day 7. The initiation of oral intake depended on the status of anastomosis according to the assessment result of esophagram. The patients whose esophagram indicated an intact anastomosis were allowed to initiate oral intake. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective cohort study reviewed patients who underwent McKeown esophagectomy. All patients routinely underwent either endoscopy or esophagram for the evaluation of anastomosis on postoperative day 7.
Key inclusion criteria (1 listed)
- The inclusion criteria required patients to have routinely undergone either endoscopy or an esophagram for the postoperative evaluation of anastomosis.
Key exclusion criteria (1 listed)
- We excluded the patient with histologically confirmed benign tumors of the esophagus or esophagogastric junction and the patient who had 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndoscopyWe first observed the residual esophagus to evaluate the mucosal color. We then reached the top of the anastomosis to obtain a full view of the anastomosis to exclude obvious leakage around that site. We next conducted a more detailed endoscopic examination at a close focal distance, circumferentially around the anastomosis. During this process, we utilized saline solution to meticulously remove white fibrin coverings and bloodstains to the greatest extent possible to ensure a thorough evaluation of anastomotic integrity. Finally, we inspected the staple line of the tubularized stomach to exclude gastric fistula and assessed the perfusion of the gastric graft. Endoscopic findings were assessed by an additional endoscopist and 3 esophageal surgeons during the examination, as well as by reviewing captured images or videos after endoscopy. | Diagnostic test | Endoscopy group |
Primary outcome
The sensitivity for detecting AL
Time frame: From January 1, 2022 to July 9, 2023
The number of the patients who is true positive for AL/ The total number of AL
The specificity for detecting AL
Time frame: From January 1, 2022 to July 9, 2023
The number of the patients who is true negative for AL/ The total number of the patients who did not develop AL
Predictive positive value for AL
Time frame: From January 1, 2022 to July 9, 2023
The number of the patients who is true positive for AL/ The number of the patients who is evaluated as AL
Predictive negative value for AL
Time frame: From January 1, 2022 to July 9, 2023
The number of the patients who is true negative for AL/ The number of the patients who is determined to have an intact anastomosis
The incidence of AL after oral intake
Time frame: From January 1, 2022 to July 9, 2023
The number of the AL that occurs after oral intake/ The number of the patients who were determined to have an intact anastomosis
2 secondary outcomes
The time from surgery to the diagnosis of AL
Time frame: From January 1, 2022 to July 9, 2023
The time required for the healing of AL
Time frame: From January 1, 2022 to July 9, 2023
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 29 Jun 2025.
- Individual participant dataSharing planned: Undecided. It has not yet been determined
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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, PhD. study chair
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer and Surgery-Complications, run by Sun Yat-sen University at 1 site 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 1 inclusion and 1 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 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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, PhD. (13560405144, yanghong@wy.sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity for detecting AL (time frame: From January 1, 2022 to July 9, 2023). The study lists 5 primary outcomes in all. 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 29 Jun 2025; AzTrials last refreshed its copy on 7 Nov 2026.