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Clinical Trials/NCT02937389
NCT02937389
Completed
Not Applicable

Endoscopic Evaluation for Predicting the Complications Related to Gastric Conduit After Esophagectomy

Nagasaki University1 site in 1 country60 target enrollmentMay 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Esophageal Neoplasms
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)
Status
Completed
Last Updated
3 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

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.

Registry
clinicaltrials.gov
Start Date
May 2015
End Date
November 2019
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kobayashi Shinichiro

Principal Investigator in department of Surgery

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

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)

Study Sites (1)

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