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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02703142
Other study ID # NagasakiU
Secondary ID
Status Completed
Phase N/A
First received January 18, 2016
Last updated October 16, 2016
Start date October 2015
Est. completion date October 2016

Study information

Verified date October 2016
Source Nagasaki University
Contact n/a
Is FDA regulated No
Health authority Japan: Ethics Committee
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:

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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender Both
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

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Procedure:
Patients after esophagectomy
postoperative endoscopic evaluation

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 Number of participants with endoscopy-related adverse events as assessed by Clavien-Dindo Classification From 1 to 29 days after esophagectomy Yes
Primary Number of participants with the classification of gastric conduit ischemia by endoscopic findings From 1 to 15 days after esophagectomy No
Primary Number of participants with the major complications of gastric conduit (strictures, leakage, necrosis) From 1 to 29 days after esophagectomy No
Secondary 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 No
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 EORTC-GCCG. European Organization for Research and Treatment of Cancer-Gynaecological Cancer Cooperative Group (J Clin Pathol. 1997 Oct; 50(10): 801-804.) From 1 to 29 days after esophagectomy No
Secondary Biological examination of gastric conduit as assessed by the Mitochondrial DNA copy number From 1 to 29 days after esophagectomy No
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