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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopy group | 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. |
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| Esophagram group | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopy | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The sensitivity for detecting AL | The number of the patients who is true positive for AL/ The total number of AL | 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 | 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 | 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 | 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 | From January 1, 2022 to July 9, 2023 |
| Measure | Description | Time Frame |
|---|---|---|
| The time from surgery to the diagnosis of AL | 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 | 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 |
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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.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hong Yang, PhD. | Contact | 13560405144 | yanghong@wy.sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hong Yang, PhD. | Sun Yat-sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510030 | China |
It has not yet been determined
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
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|
| From January 1, 2022 to July 9, 2023 |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013514 | Surgical Procedures, Operative |