Clinical trial NCT02703142: Endoscopic Evaluation After Esophagectomy
Official title: Endoscopic Evaluation for the Postoperative Condition After Esophagectomy and Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Neoplasms
Constriction
Anastomotic Leak
Ischemia
Keywords: esophagogastrostomy
gastric conduit ischemia
endoscopy
Lead sponsor: Nagasaki University
Sponsor class: OTHER
First posted: 2016-03-09
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergo an esophagectomy with reconstruction by a gastric pull-up for malignant or end-stage benign esophageal disease. The patients have a cervical esophagogastrostomy.

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.

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

Primary outcomes:
measure: Number of participants with endoscopy-related adverse events as assessed by Clavien-Dindo Classification
timeFrame: From 1 to 29 days after esophagectomy
measure: Number of participants with the classification of gastric conduit ischemia by endoscopic findings
timeFrame: From 1 to 15 days after esophagectomy
measure: Number of participants with the major complications of gastric conduit (strictures, leakage, necrosis)
timeFrame: From 1 to 29 days after esophagectomy
Secondary outcomes:
measure: Biological examination of the mucosal biopsy of gastric conduit as assessed by the ischemia related RNA copy number
timeFrame: From 1 to 29 days after esophagectomy
measure: Biological examination of the mucosal biopsy of gastric conduit as assessed by the scoring system for immunohistochemical staining
timeFrame: From 1 to 29 days after esophagectomy
measure: Biological examination of gastric conduit as assessed by the Mitochondrial DNA copy number
timeFrame: From 1 to 29 days after esophagectomy
Other outcomes:
Locations:
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
Study officials:
affiliation: Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences,
name: Shinichiro Kobayashi
role: STUDY_DIRECTOR
References: