Endoscopic Evaluation After Esophagectomy

Study Overview
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Brief Summary
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Gastric conduit ischemia or anastomotic breakdown after esophagectomy with cervical esophagogastrostomy often cause severe complications, such as leakage, necrotic organs, and strictures. Thus, the purpose of this study is the safety and efficacy of endoscopic evaluation about reconstructive organs after esophagectomy. The investigators evaluate endoscopic predictions using classifications in acute phase after esophagogastrostomy.

Detailed Description
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Gastric conduit ischemia or anastomotic breakdown after esophagectomy with cervical esophagogastrostomy often cause severe complications, such as leakage, necrotic organs, and strictures. However the evaluation and prevention before developing gastric conduit ischemia have been established. The investigators have built a hypothesis that the evaluation for gastric mucosal ischemia in early phase after esophagectomy predict the complication of gastric conduit. Thus, the purpose of this study is the safety and efficacy of endoscopic evaluation about reconstructive organs after esophagectomy. The investigators evaluate endoscopic predictions using classifications in acute phase after esophagogastrostomy.

Official Title
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Endoscopic Evaluation for the Postoperative Condition After Esophagectomy and Reconstruction

Conditions
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Esophageal Neoplasms, Constriction, Anastomotic Leak, Ischemia

Intervention / Treatment
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* Procedure: Patients after esophagectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Malignant or end-stage benign esophageal disease. Esophagectomy with reconstruction by a gastric pull-up. Exclusion Criteria: Severe heart failure and pulmonary dysfunction Severe renal and liver dysfunction Allergenic history Pregnancy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients after esophagectomy<br>Endoscopic examinations are performed at 1, 8, and 15 postoperative days. Endoscopic examination is added when abnormal findings are demonstrated. | Procedure: Patients after esophagectomy<br>* postoperative endoscopic evaluation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with endoscopy-related adverse events as assessed by Clavien-Dindo Classification |  | From 1 to 29 days after esophagectomy | 
| Number of participants with the classification of gastric conduit ischemia by endoscopic findings |  | From 1 to 15 days after esophagectomy | 
| Number of participants with the major complications of gastric conduit (strictures, leakage, necrosis) |  | From 1 to 29 days after esophagectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biological examination of the mucosal biopsy of gastric conduit as assessed by the ischemia related RNA copy number |  | From 1 to 29 days after esophagectomy | 
| Biological examination of the mucosal biopsy of gastric conduit as assessed by the scoring system for immunohistochemical staining | The scoring system refer to the article entitled a scoring system for immunohistochemical staining: consensus report of the task force for basic research of the EORTC-GCCG. European Organization for Research and Treatment of Cancer-Gynaecological Cancer Cooperative Group (J Clin Pathol. 1997 Oct; 50(10): 801-804.) | From 1 to 29 days after esophagectomy | 
| Biological examination of gastric conduit as assessed by the Mitochondrial DNA copy number |  | From 1 to 29 days after esophagectomy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esophagogastrostomy, gastric conduit ischemia, endoscopy