UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053458 |
|---|---|
| Receipt number | R000060995 |
| Scientific Title | Relationship between early extubation and postoperative outcomes after esophagectomy in patients with thoracic esophageal cancer |
| Date of disclosure of the study information | 2024/02/01 |
| Last modified on | 2024/01/27 09:50:35 |
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Basic information
Public title
Relationship between early extubation and postoperative outcomes after esophagectomy in patients with thoracic esophageal cancer
Acronym
Impact of early extubation after esophagectomy
Scientific Title
Relationship between early extubation and postoperative outcomes after esophagectomy in patients with thoracic esophageal cancer
Scientific Title:Acronym
Impact of early extubation after esophagectomy
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery | Anesthesiology | Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Esophagectomy for esophageal cancer is highly invasive among surgical procedures, and the morbidity and mortality remains high. Overnight mechanical ventilation and extubation on postoperative day 1 was historically selected to avoid postoperative adverse events. However, early extubation was introduced to prevent the pulmonary complication and promot early ambulation and early recovery.
This study aims to determine the impact of early extubation strategies after esophageal cancer surgery on major outcomes including the postoperative complications.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Major postoperative complications based on Clavien-Dindo classification
Including respiratory complications (pneumonia, atelectasis/impaired sputum drainage, tracheal fistula/bronchial fistula, pulmonary fistula, pleural effusion, chylothorax), infectious complications (wound infection, suture failure, sepsis) and thrombotic complications ( myocardial infarction, stroke, pulmonary embolism, deep vein thrombosis)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who underwent radical esophagectomy with thoracoscopic assistance for esophageal cancer between September 1, 2018, and August 31, 2023 and were admitted to the intensive care unit.
2. Patients aged 18 years or older at surgery
Key exclusion criteria
Cases in which the surgical procedure had changed to open heart surgery
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | Shuji |
| Middle name | |
| Last name | Okahara |
Organization
Okayama Univarsity Hospital
Division name
Department of Intensive Care
Zip code
7008558
Address
2-5-1 Shikatacho, Kitaku, Okayama city
TEL
086-235-7778
shuji.okahara@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Shuji |
| Middle name | |
| Last name | Okahara |
Organization
Okayama Univarsity Hospital
Division name
Department of Intensive Care
Zip code
7008558
Address
2-5-1 Shikatacho, Kitaku, Okayama city
TEL
086-235-7778
Homepage URL
shuji.okahara@okayama-u.ac.jp
Sponsor or person
Institute
Okayama Univarsity
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama Univarsity
Address
2-5-1 Shikatacho, Kitaku, Okayama city
Tel
086-235-6938
mae6605@adm.okayama-u.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
| 2024 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a retrospective observational study with an observation period from September 2018 to August 2023.
Cases who underwent surgery for esophageal cancer before early extubation strategy (September 2018 to March 2021) (conventional group) and those who underwent surgery after the strategy (April 2021 to August 2023) are retrospectively collected.
We extract cases extubated on the surgery day after esophagectomy from April 2021 to August 2023 (early extubation group). To control for potential differences in patient characteristics between groups, propensity score matching is used to compare clinical outcomes.
Management information
Registered date
| 2024 | Year | 01 | Month | 27 | Day |
Last modified on
| 2024 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060995
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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