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.
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 Type
OBSERVATIONAL
Enrollment
2
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.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGThe sensitivity for detecting AL
The number of the patients who is true positive for AL/ The total number of AL
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From January 1, 2022 to July 9, 2023
The time from surgery to the diagnosis of AL
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
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
Time frame: From January 1, 2022 to July 9, 2023
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