UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057302 |
|---|---|
| Receipt number | R000065502 |
| Scientific Title | A phase II randomized control trial of laparoscopic surgery vs hand-assisted laparoscopic surgery in thoracoscopic/robot assisted radical esophagectomy for thoracic esophageal cancer |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/03/16 17:28:47 |
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Basic information
Public title
A phase II randomized control trial of laparoscopic surgery vs hand-assisted laparoscopic surgery in thoracoscopic/robot assisted radical esophagectomy for thoracic esophageal cancer
Acronym
A phase II randomized control trial of laparoscopic surgery vs hand-assisted laparoscopic surgery in thoracoscopic/robot assisted radical esophagectomy for thoracic esophageal cancer
Scientific Title
A phase II randomized control trial of laparoscopic surgery vs hand-assisted laparoscopic surgery in thoracoscopic/robot assisted radical esophagectomy for thoracic esophageal cancer
Scientific Title:Acronym
A phase II randomized control trial of laparoscopic surgery vs hand-assisted laparoscopic surgery in thoracoscopic/robot assisted radical esophagectomy for thoracic esophageal cancer
Region
| Japan |
Condition
Condition
thoracic esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy and safety of laparoscopic surgery compared with hand-assisted laparoscopic surgery in abdominal part for thoracoscopic/robot assisted subtotal esophagectomy for thoracic esophageal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
incidence of postoperative pulmonary complications (Clavien-Dindo Grade II or higher)
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
surgical approach in abdominal part
Group A: Hand-assisted laparoscopic surgery
Interventions/Control_2
surgical approach in abdominal part
Group B:Laparoscopic surgery
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who are planed to undergo thoracoscopic or robot assisted subtotal esophagectomy with retrosternal gastric tube reconstruction for thoracic esophageal cancer.
2) cT1-4a, N0-3, M0 or M1 (#104) according to UICC-TNM 8th edition.
5) Age 20 years or older.
6) Performance status (PS) is 0 or 1 according to ECOG criteria.
7) No history of treatment for esophageal cancer. Following history of treatment are eligible.
Curative resection by EMR/ESD with pT1a-LPM (M2) or less, pT1a-MM (M3) and negative for vascular invasion.
8) No history of upper abdominal surgery or surgery involving intestinal resection. (Appendectomy and laparoscopic cholecystectomy are eligible).
9) Sufficient organ functions.
i. WBC >= 3,000/mm3
ii. Platelet >= 100000 /mm3
iii. Hemoglobin >= 8.0 g/dL
iv. T.Bil =< 2.0 mg/dL
v. AST =< 100 U/L
vi. ALT =< 100 U/L
vii. Creatinine =< 2.0 mg/dL
viii. SpO2 >= 95%
10) Written informed consent.
Key exclusion criteria
1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy.
2) Infectious disease with systemic therapy indicated.
3) Body temperature of 38 or more degrees Celsius.
4) Pregnancy, possible pregnancy, within 28 days after delivery or breast-feeding.
5) Severe psychiatric disease.
6) Continuous systemic steroid or immune-suppressive drug therapy.
7) Unstable angina pectoris, or history of myocardial infarction within six months.
8) Severe pulmonary fibrosis or emphysema.
9) Poorly controlled hypertension.
10) Poorly controlled diabetes mellitus in spite of continuous use of insulin.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Doki |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Gastroenterological Surgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita City, Osaka
TEL
06-6879-3251
ydoki@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Hamakawa |
Organization
Osaka Rosai Hospital
Division name
Surgery
Zip code
591-8025
Address
1179-3 Nagasonecho, Kita-ku, Sakai City, Osaka
TEL
072-252-3561
Homepage URL
hamakawa@osakah.johas.go.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
none
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
Ethical Review Board Osaka University Hospital
Address
2-2 Yamadaoka, Suita City, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-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
| 2025 | Year | 04 | 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 | 06 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | 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
| 2025 | Year | 03 | Month | 16 | Day |
Last modified on
| 2025 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065502
