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Recruiting NCT07043491

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

— Observational Esophageal Cancer Surgery-Complications

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endoscopy.
Who it may be relevant to
Registry conditions: Esophageal Cancer, Surgery-Complications. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed 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.

Interventions

  • Diagnostic test 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

Primary outcome measures

  • The sensitivity for detecting AL [Time frame: From January 1, 2022 to July 9, 2023]
  • The specificity for detecting AL [Time frame: From January 1, 2022 to July 9, 2023]
  • Predictive positive value for AL [Time frame: From January 1, 2022 to July 9, 2023]
  • Predictive negative value for AL [Time frame: From January 1, 2022 to July 9, 2023]
  • The incidence of AL after oral intake [Time frame: From January 1, 2022 to July 9, 2023]
Secondary outcome measures (2)
  • 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 [Time frame: From January 1, 2022 to July 9, 2023]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Sun Yat-sen University Cancer Center — Guangzhou

Identifiers

NCT: NCT07043491 · B2024-656-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗