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NCT Number: NCT07043491

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510030, China

Location status: Recruiting

Location contact

Hong Yang, PhD.

CONTACT

[email protected]

13560405144

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. The sensitivity for detecting AL

    Time frame: From January 1, 2022 to July 9, 2023

    The number of the patients who is true positive for AL/ The total number of AL

  2. The specificity for detecting AL

    Time frame: From January 1, 2022 to July 9, 2023

    The number of the patients who is true negative for AL/ The total number of the patients who did not develop AL

  3. Predictive positive value for AL

    Time frame: From January 1, 2022 to July 9, 2023

    The number of the patients who is true positive for AL/ The number of the patients who is evaluated as AL

  4. Predictive negative value for AL

    Time frame: From January 1, 2022 to July 9, 2023

    The number of the patients who is true negative for AL/ The number of the patients who is determined to have an intact anastomosis

  5. The incidence of AL after oral intake

    Time frame: From January 1, 2022 to July 9, 2023

    The number of the AL that occurs after oral intake/ The number of the patients who were determined to have an intact anastomosis

Secondary outcomes

  1. The time from surgery to the diagnosis of AL

    Time frame: From January 1, 2022 to July 9, 2023

    The time from surgery to the diagnosis of AL

  2. The time required for the healing of AL

    Time frame: From January 1, 2022 to July 9, 2023

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Hong Yang, PhD.

CONTACT

[email protected]

13560405144

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 29, 2025
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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