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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02937389
Other study ID # 16082202
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2015
Est. completion date November 2019

Study information

Verified date April 2023
Source Nagasaki University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date November 2019
Est. primary completion date November 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years to 84 Years
Eligibility 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

Study Design


Intervention

Diagnostic Test:
Patients after esophagectomy
Endoscopic examinations are performed at 1 and 8 postoperative days. Endoscopic examination is added when abnormal findings are demonstrated.

Locations

Country Name City State
Japan Nagasaki University Hospital Nagasaki

Sponsors (1)

Lead Sponsor Collaborator
Nagasaki University

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The classification of gastric conduit ischemia by endoscopic findings predicts the major complications of gastric conduit (strictures, leakage, necrosis) From 1 to 29 days after esophagectomy
Secondary 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
Secondary 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 From 1 to 15 days after esophagectomy
Secondary Biological examination of gastric conduit as assessed by the Mitochondrial DNA copy number From 1 to 15 days after esophagectomy
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