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

Esophageal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02937389
• Other study ID #: 16082202
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Anastomotic Leak
• Constriction
• Esophageal Neoplasms
• Ischemia

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