UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043544 |
|---|---|
| Receipt number | R000049726 |
| Scientific Title | Comparison of blood gases during thracoscopic-laparoscopic esophagectomy and open esophagectomy |
| Date of disclosure of the study information | 2021/10/31 |
| Last modified on | 2025/09/08 22:44:46 |
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Basic information
Public title
Comparison of blood gases during thracoscopic-laparoscopic esophagectomy and open esophagectomy
Acronym
Comparison of blood gases during thracoscopic-laparoscopic esophagectomy and open esophagectomy
Scientific Title
Comparison of blood gases during thracoscopic-laparoscopic esophagectomy and open esophagectomy
Scientific Title:Acronym
Comparison of blood gases during thracoscopic-laparoscopic esophagectomy and open esophagectomy
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
blood gases changes during thoracoscopic-laparoscopic esophagectomy and open esophagectomy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
oxygenation and carbon dioxide changes during thoracoscopic-laparoscopic esophagectomy and open esophagectomy
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
esophageal cancer patients
Key exclusion criteria
pulmonary obstructive lung disease
heart disease
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Daizoh |
| Middle name | |
| Last name | Satoh |
Organization
Juntendo University
Division name
department of anestheiology and pain medicine
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
da-sato@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Daizoh |
| Middle name | |
| Last name | Satoh |
Organization
Juntendo University
Division name
department of anesthesiology and pain medicine
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-kum Tokyo
TEL
03-3813-3111
Homepage URL
da-sato@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo university
Address
2-1-1, Hongo, Bunkyo-ku
Tel
03-3813-3111
kenkyu5858@juntendo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 31 | Day |
Related information
URL releasing protocol
Juntendo Medical Journal 2025; 71: 180-186
Publication of results
Partially published
Result
URL related to results and publications
Juntendo Medical Journal 2025; 71: 180-186
Number of participants that the trial has enrolled
75
Results
the patients were older (p < 0.05) and the operative time was longer (p < 0.01) in Group E than in Group O. At T2, PaO2/FIO2 was lower (p < 0.01) and PaCO2 was higher (p < 0.01) in Group E than in Group O, although these variables did not differ between groups at T1 or T4. Post operative data showed shorter ICU (p<0.01) and hospital stay (p<0.05) in Group E than in Group O but showed no significant difference in the presence of complications.
Results date posted
| 2025 | Year | 09 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 08 | Month | 05 | Day |
Baseline Characteristics
Minimally invasive thoracoscopic esophagectomy may result in superior post-operative outcomes compared to open esophagectomy. We compared arterial blood gas data during one-lung ventilation (OLV) between thoracoscopic esophagectomy and open esophagectomy.
Participant flow
37 patients undergoing thoracoscopic esophagectomy (Group E) and 38 patients undergoing open esophagectomy (Group O) were investigated.
Adverse events
None
Outcome measures
We retrospectively studied patients who underwent open and intrathoracoscopic esophagectomy for esophageal cancer between January 2017 and May 2021. Patients with an ASA-PS class 3 or more, those without complete arterial blood gas data sets and those who required conversion to an open procedure were excluded. We retrospectively investigated 75 patients comprising 37 patients who underwent intrathoracoscopic esophagectomy (Group E) and 38 patients who underwent open esophagectomy (Group O). Data on patients' intra-operative clinical characteristics were reviewed. The duration of surgery, anesthesia and OLV was collected. Intra-operative crystalloid and transfusion requirements, blood loss and urine output were reviewed as well.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2021 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2021 | Year | 03 | Month | 07 | Day |
Last modified on
| 2025 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049726
| Research Plan | |
|---|---|
| Registered date | File name |
| 2025/09/09 | 2024.9.22 manuscript.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2025/09/09 | 2024.9.25 manuscript.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2025/09/09 | 2024.12.31manuscript.docx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/49726
