UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050677 |
|---|---|
| Receipt number | R000057741 |
| Scientific Title | Gastric Tube versus Whole Stomach Reconstruction after Esophagectomy for Esophageal Cancer: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2023/03/26 |
| Last modified on | 2023/09/26 21:23:08 |
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Basic information
Public title
Gastric Tube versus Whole Stomach Reconstruction after Esophagectomy for Esophageal Cancer: A Randomized Controlled Trial
Acronym
ATHLETE trial
Scientific Title
Gastric Tube versus Whole Stomach Reconstruction after Esophagectomy for Esophageal Cancer: A Randomized Controlled Trial
Scientific Title:Acronym
ATHLETE trial
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will compare the incidence of anastomotic leakage in narrow gastric tube reconstruction and whole stomach reconstruction. In addition, we will evaluate complications such as anastomotic stenosis, perioperative course, body weight change, QOL, etc. in both reconstruction methods in the short and medium term, and clarify the optimal gastric tube preparation method for reconstruction after esophagectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Incidence of anastomotic leakage
Key secondary outcomes
Occurrence rate of anastomotic stenosis
Occurrence rate of pneumonia
Occurrence rate of all postoperative complications
Occurrence rate of reflux esophagitis
QOL evaluation by EORTC QLQ-C30 and EORTC OES-18
Nutritional evaluation
Amount of blood loss
Postoperative hospital stay
Blood flow evaluation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
standard treatment group: narrow gastric tube reconstruction
Interventions/Control_2
experimental treatment group: whole stomach reconstruction
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with thoracic esophageal cancer whose tumor does not extend to the cervical esophagus
2) Patients who are used the stomach as a reconstructed organ and undergo reconstruction by either the posterior mediastinal route or the retrosternal route
3) Patients undergoing anastomosis in the neck
4) Patients who undergo 2-field or 3-field dissection
5) Patients aged between 18 and 85 years old at the time of enrollment
6) Patients who have given informed consent
Key exclusion criteria
1) Patients judged to be unable to undergo either narrow gastric tube or whole stomach reconstruction due to intraoperative findings
2) Patients with serious complications (interstitial pneumonia or pulmonary fibrosis, difficult-to-control diabetes, ischemic heart disease requiring treatment, heart failure, etc.)
3) Patients with moderate or severe hepatic or renal dysfunction
4) Patients with cirrhosis or active hepatitis
5) Patients undergoing dialysis
6) Patients judged inappropriate by the attending physician
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Junya |
| Middle name | |
| Last name | Kitadani |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
641-8510
Address
Kimiidera811-1, Wakayama, Japan
TEL
073-441-0613
kitadani@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Junya |
| Middle name | |
| Last name | Kitadani |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
641-8510
Address
Kimiidera811-1, Wakayama, Japan
TEL
073-441-0613
Homepage URL
kitadani@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics Committee of Wakayama Medical University
Address
Kimiidera 811-1, Wakayama, Japan
Tel
073-447-2300
wa-rinri@wakayama-med.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
和歌山県立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 26 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 27 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 26 | Day |
Last modified on
| 2023 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057741
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| Registered date | File name |
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