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

Sun Yat-sen University

Status: Enrolling

Conditions: Surgery-Complications; Esophageal Cancer

Treatments: Diagnostic Test: Endoscopy

Study type: Observational

Funder types: Other

Identifiers

NCT07043491

B2024-656-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

2 participants in 2 patient groups

Endoscopy group

Description:

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.

Treatment:

Diagnostic Test: Endoscopy

Esophagram group

Description:

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.