Endoscopy versus esophagram to check the anastomosis after McKeown esophagectomy
Comparison of Endoscopy and Esophagram for the Routine Evaluation of Anastomosis After McKeown Esophagectomy
This comparison tries to see whether endoscopy or esophagram is better for checking the surgical connection about seven days after McKeown esophagectomy in patients treated for esophageal cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07043491 on ClinicalTrials.gov |
What this trial studies
This is a retrospective cohort from a single cancer center that reviewed patients who underwent McKeown esophagectomy and received either endoscopy or esophagram on postoperative day 7 to check the anastomosis. Decisions about starting oral intake were guided by the test findings, with patients showing poor healing on endoscopy monitored with weekly repeat endoscopy until healing was seen. Primary endpoints were diagnostic performance (sensitivity, specificity, PPV, NPV, and accuracy) for detecting anastomotic leak (AL) and the incidence of AL after oral intake. Secondary endpoints included time from surgery to AL diagnosis, time to AL healing, and safety outcomes with six months of follow-up.
Who should consider this trial
Good fit: Ideal candidates are patients who underwent McKeown esophagectomy for esophageal cancer and had a routine endoscopy or esophagram around postoperative day seven.
Not a fit: Patients with benign esophageal tumors (who were excluded), incomplete clinical records, different types of esophagectomy, or imaging done at different timepoints may not benefit from these findings.
Why it matters
Potential benefit: If successful, the results could help clinicians choose the safer test to start oral intake sooner and reduce missed anastomotic leaks after McKeown esophagectomy.
How similar studies have performed: Other single-center and retrospective analyses have compared endoscopy and esophagram after esophagectomy with mixed results, so this work adds additional center-specific evidence rather than introducing a wholly novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Hong Yang, PhD.
- Email: yanghong@wy.sysucc.org.cn
- Phone: 13560405144
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.