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NCT Number: NCT02703142

Endoscopic Evaluation After Esophagectomy

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.

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Key information

Conditions

Esophageal Neoplasms Anastomotic Leak Constriction Constriction, Pathologic Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Ischemia Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

20 year–84 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nagasaki University Hospital

Nagasaki, 852-8501, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patients after esophagectomy

Procedure

postoperative endoscopic evaluation

Primary outcomes

  1. Number of participants with endoscopy-related adverse events as assessed by Clavien-Dindo Classification

    Time frame: From 1 to 29 days after esophagectomy

  2. Number of participants with the classification of gastric conduit ischemia by endoscopic findings

    Time frame: From 1 to 15 days after esophagectomy

  3. Number of participants with the major complications of gastric conduit (strictures, leakage, necrosis)

    Time frame: From 1 to 29 days after esophagectomy

Secondary outcomes

  1. Biological examination of the mucosal biopsy of gastric conduit as assessed by the ischemia related RNA copy number

    Time frame: From 1 to 29 days after esophagectomy

  2. Biological examination of the mucosal biopsy of gastric conduit as assessed by the scoring system for immunohistochemical staining

    Time frame: From 1 to 29 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 EORTC-GCCG. European Organization for Research and Treatment of Cancer-Gynaecological Cancer Cooperative Group (J Clin Pathol. 1997 Oct; 50(10): 801-804.)

  3. Biological examination of gastric conduit as assessed by the Mitochondrial DNA copy number

    Time frame: From 1 to 29 days after esophagectomy

Sponsors and collaborators

Lead sponsor

Nagasaki University

Other

Registry information

Official study title

Endoscopic Evaluation for the Postoperative Condition After Esophagectomy and Reconstruction

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 9, 2016
Registry last updated
Oct 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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