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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02937389
Enrollment
60
Registered
2016-10-18
Start date
2015-05-31
Completion date
2019-11-30
Last updated
2023-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomotic Leak, Constriction, Esophageal Neoplasms, Ischemia

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.

Interventions

Endoscopic examinations are performed at 1 and 8 postoperative days. Endoscopic examination is added when abnormal findings are demonstrated.

Sponsors

Nagasaki University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 84 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frameDescription
Biological examination of the mucosal biopsy of gastric conduit as assessed by the ischemia related RNA copy numberFrom 1 to 15 days after esophagectomy
Biological examination of the mucosal biopsy of gastric conduit as assessed by the scoring system for immunohistochemical stainingFrom 1 to 15 days after esophagectomyThe 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 numberFrom 1 to 15 days after esophagectomy

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026