Endoscopic Evaluation for Predicting the Complications Related to Gastric Conduit After Esophagectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Nagasaki University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- The classification of gastric conduit ischemia by endoscopic findings predicts the major complications of gastric conduit (strictures, leakage, necrosis)
Study 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
The development and improvement of thoracoscopic esophagectomy (TE) reduced the severe pulmonary complication after esophagectomy. However, the postoperative complications relative to gastric conduit reconstruction are still common issues after esophagectomy. The ischemia of the proximal portion of the graft predisposes these patients to a high incidence of anastomotic complications after esophagectomy. Less commonly, severe graft ischemia can lead to transmural necrosis. Thus, early diagnosis of ischemic reaction may provide the suitable postoperative management and therapeutic intervention to prevent leakage, strictures and necrosis. 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 20 Years to 84 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
The classification of gastric conduit ischemia by endoscopic findings predicts 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 ischemia related RNA copy number(From 1 to 15 days after esophagectomy)
- Biological examination of the mucosal biopsy of gastric conduit as assessed by the scoring system for immunohistochemical staining(From 1 to 15 days after esophagectomy)
- Biological examination of gastric conduit as assessed by the Mitochondrial DNA copy number(From 1 to 15 days after esophagectomy)
Investigators
Kobayashi Shinichiro
Principal Investigator in department of Surgery
Nagasaki University