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

NCT07043491 | Recruiting

• 1 other identifier: B2024-656-01
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophageal Cancer; Surgery-Complications

Keywords

Esophageal cancer; Endoscopy; Esophagram; McKeown esophagectomy

Outcome Measures

Primary Outcomes (5)

• The sensitivity for detecting AL

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

  From January 1, 2022 to July 9, 2023

• The specificity for detecting AL

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

  From January 1, 2022 to July 9, 2023

• Predictive positive value for AL

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

  From January 1, 2022 to July 9, 2023

• Predictive negative value for AL

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

  From January 1, 2022 to July 9, 2023

• The incidence of AL after oral intake

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

  From January 1, 2022 to July 9, 2023

Secondary Outcomes (2)

• The time from surgery to the diagnosis of AL

  From January 1, 2022 to July 9, 2023

• The time required for the healing of AL

  From January 1, 2022 to July 9, 2023

Study Arms (2)

Endoscopy group

The patients routinely underwent either endoscopy 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. The patients 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.

Diagnostic Test: Endoscopy

Esophagram group

All patients routinely underwent 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 esophagram. The patients whose esophagram indicated an intact anastomosis were allowed to initiate oral intake.

Interventions

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.

Endoscopy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may not qualify if:

• We excluded the patient with histologically confirmed benign tumors of the esophagus or esophagogastric junction and the patient who had incomplete data.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510030, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Hong Yang, PhD.

  Sun Yat-sen University

  STUDY CHAIR

Central Study Contacts

Hong Yang, PhD.

CONTACT

13560405144; yanghong@wy.sysucc.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 29, 2025
• Study Start: November 4, 2024
• Primary Completion: July 9, 2025
• Study Completion: December 1, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Locations

CN (1)