An observational study in Esophageal Neoplasms, Constriction and Anastomotic Leak, sponsored by Nagasaki University. Completed at 1 site in Japan. Open to participants aged 20 Years to 84 Years. Per ClinicalTrials.gov, last updated 2023-04-05.
Sponsored by Nagasaki University · Observational
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.
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.
1,873 studies on the registry are indexed under Esophageal Neoplasms; 501 are open to participants now.
This study's enrollment of 60 is below the median of 200 across 432 observational studies indexed under Esophageal Neoplasms.
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Patients undergo an esophagectomy with reconstruction by a gastric pull-up for malignant or end-stage benign esophageal disease. The patients have a cervical esophagogastrostomy.
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Exclusion Criteria:
Endoscopic examinations are performed at 1 and 8 postoperative days. Endoscopic examination is added when abnormal findings are demonstrated.
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
Biological examination of the mucosal biopsy of gastric conduit as assessed by the ischemia related RNA copy number
Time frame: 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
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 European Organization for Research and Treatment of Cancer-Gynaecological Cancer Cooperative Group
Time frame: From 1 to 15 days after esophagectomy
Biological examination of gastric conduit as assessed by the Mitochondrial DNA copy number
Time frame: From 1 to 15 days after esophagectomy
Plan to share: Undecided
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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Nagasaki University