Endoscopic Evaluation After Esophagectomy

Esophageal Neoplasms Clinical Trial

Official title:

Endoscopic Evaluation for the Postoperative Condition After Esophagectomy and Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02703142
• Other study ID #: NagasakiU
• 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

Related Conditions & MeSH terms

• Anastomotic Leak
• Constriction
• Constriction, Pathologic
• Esophageal Neoplasms
• Ischemia

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

External Links

•   Protocol information in University Hospital Medical Information Network (UMIN) (UMIN000019585)