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Clinical Trials/NCT07043491
NCT07043491RecruitingNot Applicable

Comparison of Endoscopy and Esophagram for the Routine Evaluation of Anastomosis After McKeown Esophagectomy

Sun Yat-sen University1 site in 1 country2 target enrollmentStarted: November 4, 2024Last updated:
Conditions

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

Sponsor
Sun Yat-sen University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yang Hong

Professor

Sun Yat-sen University

Study Sites (1)

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