Anastomotic Leak, Constriction, Esophageal Neoplasms, Ischemia
Conditions
Keywords
esophagogastrostomy, gastric conduit ischemia, endoscopy
Brief summary
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
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.
Interventions
PROCEDUREPatients after esophagectomy
postoperative endoscopic evaluation
Sponsors
Nagasaki University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 84 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | From 1 to 29 days after esophagectomy | 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.) |
| Biological examination of gastric conduit as assessed by the Mitochondrial DNA copy number | From 1 to 29 days after esophagectomy | — |
Countries
Japan
Outcome results
None listed