Comparison of Endoscopy and Esophagram for the Routine Evaluation of Anastomosis After McKeown Esophagectomy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSun Yat-sen University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Endoscopy
Diagnostic testWe 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.
Treatment groups
2 Participants
are divided into 2 treatment groupsGroup A: Endoscopy group1 intervention
Group B: Esophagram group0 interventions
Trial outcomes
Primary outcomes
1
The 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, 20232
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, 20233
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, 20234
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, 2023Secondary outcomes
1
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, 20232
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, 2023Sponsors and contacts
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Source ClinicalTrials.gov