Endoscopic Evaluation for the Postoperative Condition After Esophagectomy and Reconstruction
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Esophageal Neoplasms
- Sponsor
- Nagasaki University
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Number of participants with endoscopy-related adverse events as assessed by Clavien-Dindo Classification
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Kobayashi Shinichiro
Assistant professor
Nagasaki University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of participants with endoscopy-related adverse events as assessed by Clavien-Dindo Classification
Time Frame: From 1 to 29 days after esophagectomy
Number of participants with the classification of gastric conduit ischemia by endoscopic findings
Time Frame: From 1 to 15 days after esophagectomy
Number of participants with the major complications of gastric conduit (strictures, leakage, necrosis)
Time Frame: From 1 to 29 days after esophagectomy
Secondary Outcomes
- 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)
- 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 gastric conduit as assessed by the Mitochondrial DNA copy number(From 1 to 29 days after esophagectomy)