- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04597398
Utility of the Evaluation of Blood Flow of the Remnant Esophagus in Esophagectomy With Pedicled Jejunum Reconstruction
October 15, 2020 updated by: Kenjiro Ishii, Shizuoka Cancer Center
Utility of the Evaluation of Blood Flow With Indocyanine Green in Setting the Anastomosis Site of the Remnant Esophagus in Esophagectomy With Pedicled Jejunum Reconstruction: A Case Series
Pedicled jejunal flap can be utilized with various tips for esophageal reconstruction in patients with a history of gastrectomy, or those who have undergone synchronous esophagogastrectomy, although the rate of anastomosis leakage is high with this technique.
Therefore, in the current study, we considered the utility of the evaluation of blood flow of the remnant esophagus with indocyanine green in setting the anastomosis site.
We included 50 patients who underwent radical esophagectomy with pedicled jejunal flap between April 2012 and June 2020.
From June 2019, the blood flow of not only the pedicled jejunum, but also the remnant esophagus were evaluated in order to set the anastomosis site of the latter because the color was not definitive criteria for judging in surgery on the remnant esophagus.
Usually, the second and third jejunal vessels are transected, and if the jejunal flap cannot reach to the anastomosis point, we actively transect the marginal vessels in order to stretch the jejunal flap.
Microvascular anastomosis between the jejunal branches (the second) and the internal thoracic vessels is usually made, and the anastomosis site is set at the part of the esophagus that is well-dyed with indocyanine green.
A total of 39 patients underwent the procedure prior to June 2019 ( Group A), and 11 patients underwent the procedure as of June 2019 (Group B).
No significant difference was found in the patients' background, type of preoperative therapy, and presence or absence of ligation of marginal vessels and two-stage operation between the two groups.
Group A had 16 cases of anastomosis leakage, while Group B only has one (P < 0.05).
There were no cases of significant pedicled jejunum graft necrosis.
Our findings demonstrate that the evaluation of the blood flow of the remnant esophagus during setting of the anastomosis site may decrease the rate of anastomosis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
50
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Between January 2011 and June 2020, 50 patients underwent esophagectomy with pedicled jejunum reconstruction at our institute.
The patients underwent subtotal esophagectomy via right thoracotomy with either an endoscopic or open procedure.
Description
Inclusion Criteria:
- patients who underwent radical esophagectomy with pedicled jejunal flap between April 2012 and June 2020
Exclusion Criteria:
- patients who did not complete the esophagectomy
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group A
A total of 39 patients underwent the procedure prior to June 2019
|
|
Group B
11 patients underwent the procedure as of June 2019
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
anastomosis leakage
Time Frame: 1months after surgery
|
the rate of anastomosis leakage between remnant esophagus and pedicled jejunum
|
1months after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
April 1, 2012
Primary Completion (Actual)
June 30, 2020
Study Completion (Actual)
July 30, 2020
Study Registration Dates
First Submitted
October 15, 2020
First Submitted That Met QC Criteria
October 15, 2020
First Posted (Actual)
October 22, 2020
Study Record Updates
Last Update Posted (Actual)
October 22, 2020
Last Update Submitted That Met QC Criteria
October 15, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- ShizuokaCC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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