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

April 2, 2023 updated by: Kobayashi Shinichiro, Nagasaki University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Nagasaki, Japan, 852-8501
        • Nagasaki University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The classification of gastric conduit ischemia by endoscopic findings predicts the major complications of gastric conduit (strictures, leakage, necrosis)
Time Frame: From 1 to 29 days after esophagectomy
From 1 to 29 days after esophagectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biological examination of the mucosal biopsy of gastric conduit as assessed by the ischemia related RNA copy number
Time Frame: From 1 to 15 days after esophagectomy
From 1 to 15 days after esophagectomy
Biological examination of the mucosal biopsy of gastric conduit as assessed by the scoring system for immunohistochemical staining
Time Frame: From 1 to 15 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 European Organization for Research and Treatment of Cancer-Gynaecological Cancer Cooperative Group
From 1 to 15 days after esophagectomy
Biological examination of gastric conduit as assessed by the Mitochondrial DNA copy number
Time Frame: From 1 to 15 days after esophagectomy
From 1 to 15 days after esophagectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nagasaki University

Investigators

  • Study Director: Shinichhiro Kobayashi, M.D., Nagasaki University Graduate School of Biomedical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

October 17, 2016

First Submitted That Met QC Criteria

October 17, 2016

First Posted (Estimate)

October 18, 2016

Study Record Updates

Last Update Posted (Actual)

April 5, 2023

Last Update Submitted That Met QC Criteria

April 2, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16082202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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