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

Completed

• Conditions: Esophageal Neoplasms; Constriction; Anastomotic Leak; Ischemia

• Registration Number: NCT02937389
• 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

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.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2016-10-17
• Study First Submitted QC: 2016-10-17
• Study First Posted: 2016-10-18
• Primary Completion: 2018-11
• Study Completion: 2019-11
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-02
• Last Update Posted: 2023-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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	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
Biological examination of gastric conduit as assessed by the Mitochondrial DNA copy number	From 1 to 15 days after esophagectomy

Trial Locations

Locations (1)

Nagasaki University Hospital; 🇯🇵 Nagasaki, Japan