Endoscopic Evaluation After Esophagectomy

Completed

• Conditions: Esophageal Neoplasms; Anastomotic Leak; Ischemia; Constriction
• Interventions: Procedure: Patients after esophagectomy

• Registration Number: NCT02703142
• Lead Sponsor: Nagasaki University

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

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-01-18
• Study First Submitted QC: 2016-03-08
• Study First Posted: 2016-03-09
• Status Verified: 2016-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2016-10-16
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients after esophagectomy	Patients after esophagectomy	Endoscopic examinations are performed at 1, 8, and 15 postoperative days. Endoscopic examination is added when abnormal findings are demonstrated.

Primary Outcome Measures

Name	Time	Method
Number of participants with endoscopy-related adverse events as assessed by Clavien-Dindo Classification	From 1 to 29 days after esophagectomy
Number of participants with the classification of gastric conduit ischemia by endoscopic findings	From 1 to 15 days after esophagectomy
Number of participants with the major complications of gastric conduit (strictures, leakage, necrosis)	From 1 to 29 days after esophagectomy

Secondary Outcome Measures

Name	Time	Method
Biological examination of the mucosal biopsy of gastric conduit as assessed by the scoring system for immunohistochemical staining	From 1 to 29 days after esophagectomy	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.)
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
Biological examination of gastric conduit as assessed by the Mitochondrial DNA copy number	From 1 to 29 days after esophagectomy

Trial Locations

Locations (1)

Nagasaki University Hospital; 🇯🇵 Nagasaki, Japan