Endoscopic Evaluation After Esophagectomy

NCT ID: NCT02703142

Last Updated: 2016-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-10-31

Brief Summary

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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

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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.

Conditions

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Esophageal Neoplasms Constriction Anastomotic Leak Ischemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients after esophagectomy

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

Patients after esophagectomy

Intervention Type PROCEDURE

postoperative endoscopic evaluation

Interventions

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Patients after esophagectomy

postoperative endoscopic evaluation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nagasaki University

OTHER

Sponsor Role lead

Responsible Party

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Kobayashi Shinichiro

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shinichiro Kobayashi

Role: STUDY_DIRECTOR

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

Locations

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Nagasaki University Hospital

Nagasaki, Nagasaki, Japan

Site Status

Countries

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Japan

Related Links

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https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000022640&language=J

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

Other Identifiers

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NagasakiU

Identifier Type: -

Identifier Source: org_study_id

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