UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059630 |
|---|---|
| Receipt number | R000068002 |
| Scientific Title | A Randomized Controlled Trial Evaluating the Utility of Preserving the Posterior Pulmonary Nerve Plexus During Mediastinal Lymph Node Dissection for Esophageal Cancer |
| Date of disclosure of the study information | 2025/11/04 |
| Last modified on | 2025/11/03 23:12:25 |
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Basic information
Public title
A Randomized Controlled Trial Evaluating the Utility of Preserving the Posterior Pulmonary Nerve Plexus During Mediastinal Lymph Node Dissection for Esophageal Cancer
Acronym
A Randomized Controlled Trial Evaluating the Utility of Preserving the Posterior Pulmonary Nerve Plexus During Mediastinal Lymph Node Dissection for Esophageal Cancer
Scientific Title
A Randomized Controlled Trial Evaluating the Utility of Preserving the Posterior Pulmonary Nerve Plexus During Mediastinal Lymph Node Dissection for Esophageal Cancer
Scientific Title:Acronym
A Randomized Controlled Trial Evaluating the Utility of Preserving the Posterior Pulmonary Nerve Plexus During Mediastinal Lymph Node Dissection for Esophageal Cancer
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether preservation of the posterior pulmonary plexus of automatic nerve during thoracoscopic and robot-assisted subtotal esophagectomy for thoracic esophageal cancer reduces postoperative respiratory complications such as chronic cough and pneumonia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence rate of postoperative chronic cough
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Preserve the Posterior Pulmonary Plexus of autonomic nerve
Preserving group
Interventions/Control_2
Not preserving the Posterior Pulmonary Plexus of autonomic nerve
None preserving group
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
Patients who are planned to undergo esophagectomy with middle to lower esophageal cancer with clinical stage I-IVA
Patients are older than 18 years old
Performance status (PS) is 0 to 2 according to ECOG criteria
Patients who consented with own free will to this study after receiving sufficient explanation and with adequate understanding
Key exclusion criteria
cases which tumor invaded to posterior pulmonary nerve plexus of autonomic nerve
Cases that are currently cancer-bearing other than esophageal cancer
Cases with severe respiratory disorders such as pulmonary emphysema, interstitial pneumonia, or bronchial asthma
Cases with severe liver dysfunction, cirrhosis, or active hepatitis
Cases with severe renal dysfunction
Cases with poorly controlled diabetes
Pregnant women or those who may be pregnant, women who are breastfeeding
Cases diagnosed inappropriate to conduct this research safely by principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Yamasaki |
Organization
Kansai Medical University
Division name
Department of Upper Gastrointestinal Surgery
Zip code
573-1010
Address
2-5-1 Shinmachi, Hirakata, Osaka, 573-1010, Japan
TEL
072-804-0101
yamasaki.mak@kmu.ac.jp
Public contact
Name of contact person
| 1st name | Takuji |
| Middle name | |
| Last name | Sato |
Organization
Kansai Medical University
Division name
Department of Upper Gastrointestinal Surgery
Zip code
573-1010
Address
2-5-1 Shinmachi, Hirakata, Osaka, 573-1010, Japan
TEL
072-804-0101
Homepage URL
satou.tak@kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Johnson And Johnson MedTech Research Grant
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University
Address
2-5-1 Shinmachi, Hirakata, Osaka, 573-1010, Japan
Tel
072-804-0101
satou.tak@kmu.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
| 2025 | Year | 11 | Month | 04 | 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
| 2025 | Year | 11 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 03 | Day |
Last modified on
| 2025 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068002
