Endoscopic Evaluation After Esophagectomy

NCT02703142 | Completed DMC

• 1 other identifier: NagasakiU
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Neoplasms; Constriction; Anastomotic Leak; Ischemia

Keywords

esophagogastrostomy; gastric conduit ischemia; endoscopy

Outcome Measures

Primary Outcomes (3)

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

  From 1 to 29 days after esophagectomy

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

  From 1 to 15 days after esophagectomy

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

  From 1 to 29 days after esophagectomy

Secondary Outcomes (3)

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

  From 1 to 29 days after esophagectomy

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

  From 1 to 29 days after esophagectomy

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

  From 1 to 29 days after esophagectomy

Study Arms (1)

Patients after esophagectomy

Endoscopic examinations are performed at 1, 8, and 15 postoperative days. Endoscopic examination is added when abnormal findings are demonstrated.

Procedure: Patients after esophagectomy

Interventions

Patients after esophagectomy PROCEDURE

postoperative endoscopic evaluation

Patients after esophagectomy

Eligibility Criteria

• Age: 20 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Malignant or end-stage benign esophageal disease.
• Esophagectomy with reconstruction by a gastric pull-up.

You may not qualify if:

• Severe heart failure and pulmonary dysfunction
• Severe renal and liver dysfunction
• Allergenic history
• Pregnancy

Sponsors & Collaborators

• Nagasaki University: lead

Study Sites (1)

Nagasaki University Hospital

Nagasaki, Nagasaki, 852-8501, Japan

Location

Related Links

• Protocol information in University Hospital Medical Information Network (UMIN) （UMIN000019585）

Biospecimen

Retention: SAMPLES WITH DNA

dmp-DNA

MeSH Terms

Conditions

Esophageal Neoplasms; Constriction, Pathologic; Anastomotic Leak; Ischemia

Condition Hierarchy (Ancestors)

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

Study Officials

• Shinichiro Kobayashi

  Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences,

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: March 9, 2016
• Study Start: October 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 18, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

JP (1)