Actively Recruiting

Age: 18Years +
All Genders
ID07043491

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

Led by Sun Yat-sen University · Updated on 2025-06-29

2

Participants Needed

1

Research Sites

20 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are evaluating the use of endoscopy and esophagram to routinely check the healing of anastomosis after McKeown esophagectomy, a surgical procedure for esophageal cancer. This retrospective cohort study aims to compare the effectiveness of these two methods in detecting anastomotic leaks and their accuracy in assessing healing. Patients were monitored for six months following the anastomosis assessment to understand healing progress and complications. Patients were divided into two groups. One group underwent endoscopy on postoperative day 7, where detailed examination of the anastomosis was performed, including cleaning the area for clear view and inspecting for leaks or poor healing. If poor healing was found, weekly repeat endoscopies delayed oral intake until improvement. The other group underwent esophagram on postoperative day 7, and if the anastomosis appeared intact, oral intake was started. This study assessed how the evaluation method affected the timing of oral intake after surgery. During the study, patients' healing and complications were tracked through the endoscopy or esophagram results, with follow-up lasting six months. Researchers measured the sensitivity, specificity, positive and negative predictive values for detecting leaks, and the incidence of leaks after starting oral intake. Secondary outcomes included the time from surgery to leak diagnosis and the time needed for leaks to heal. Safety and accuracy of the evaluation methods were also monitored throughout the follow-up period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who routinely underwent either endoscopy or esophagram for postoperative evaluation of anastomosis
  • Adults aged 18 years or older
Not Eligible

You will not qualify if you...

  • Patients with histologically confirmed benign tumors of the esophagus or esophagogastric junction
  • Patients with incomplete data

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo either an endoscopy or an esophagram on postoperative day 7 to evaluate the healing of the anastomosis after McKeown esophagectomy.

1 visit (in-person) on postoperative day 7

Long-term Monitoring

Duration - 6 months

Participants with poor healing anastomosis on endoscopy are monitored with weekly repeat endoscopies until healing is confirmed. All participants are followed for six months after the initial anastomosis assessment.

Weekly visits for repeat endoscopy if needed, plus follow-up visits over six months

Trial Site Locations

Total: 1 location

1

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510030

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Research Team

H

Hong Yang, PhD.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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