Actively Recruiting
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
On this page
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
Eligibility Criteria
You may qualify if you...
- Patients who routinely underwent either endoscopy or esophagram for postoperative evaluation of anastomosis
- Adults aged 18 years or older
You will not qualify if you...
- Patients with histologically confirmed benign tumors of the esophagus or esophagogastric junction
- Patients with incomplete data
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Actively Recruiting
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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