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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест Endoscopy
  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 evaluatio

Первичные конечные точки

• The sensitivity for detecting AL [Срок оценки: From January 1, 2022 to July 9, 2023]
• The specificity for detecting AL [Срок оценки: From January 1, 2022 to July 9, 2023]
• Predictive positive value for AL [Срок оценки: From January 1, 2022 to July 9, 2023]
• Predictive negative value for AL [Срок оценки: From January 1, 2022 to July 9, 2023]
• The incidence of AL after oral intake [Срок оценки: From January 1, 2022 to July 9, 2023]

Вторичные конечные точки (2)

• The time from surgery to the diagnosis of AL [Срок оценки: From January 1, 2022 to July 9, 2023]
• The time required for the healing of AL [Срок оценки: From January 1, 2022 to July 9, 2023]

Критерии участия

Критерии включения

The inclusion criteria required patients to have routinely undergone either endoscopy or an esophagram for the postoperative evaluation of anastomosis.

Критерии исключения

We excluded the patient with histologically confirmed benign tumors of the esophagus or esophagogastric junction and the patient who had incomplete data.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Sun Yat-sen University Cancer Center — Гуанчжоу

Идентификаторы

NCT: NCT07043491 · B2024-656-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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