Clinical trial NCT02937389: Endoscopic Evaluation for Predicting the Complications Related to Gastric Conduit After Esophagectomy
Official title: Endoscopic Evaluation for Predicting the Complications Related to Gastric Conduit After Esophagectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Neoplasms
Constriction
Anastomotic Leak
Ischemia
Lead sponsor: Nagasaki University
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 60
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: 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.

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: The classification of gastric conduit ischemia by endoscopic findings predicts 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 15 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 15 days after esophagectomy
measure: Biological examination of gastric conduit as assessed by the Mitochondrial DNA copy number
timeFrame: From 1 to 15 days after esophagectomy
Other outcomes:
Locations:
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
Study officials:
affiliation: Nagasaki University Graduate School of Biomedical Sciences
name: Shinichhiro Kobayashi, M.D.
role: STUDY_DIRECTOR
References: