Comparison of Endoscopy and Esophagram for the Routine Evaluation of Anastomosis After McKeown Esophagectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- The sensitivity for detecting AL
Study Overview
Brief 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. 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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The inclusion criteria required patients to have routinely undergone either endoscopy or an esophagram for the postoperative evaluation of anastomosis.
Exclusion Criteria
- •We excluded the patient with histologically confirmed benign tumors of the esophagus or esophagogastric junction and the patient who had incomplete data.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- The time from surgery to the diagnosis of AL(From January 1, 2022 to July 9, 2023)
- The time required for the healing of AL(From January 1, 2022 to July 9, 2023)
Investigators
Yang Hong
Professor
Sun Yat-sen University
