UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055313 |
|---|---|
| Receipt number | R000063212 |
| Scientific Title | Feasibility study of Robot-Assisted Esophagectomy and Robot-Assisted Gastric Tube Reconstruction for the Patients with Locally Advanced Esophageal Carcinoma with the HinotoriTM Surgical Robot System |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2024/08/22 23:30:31 |
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Basic information
Public title
Feasibility study of Robot-Assisted Esophagectomy and Robot-Assisted Gastric Tube Reconstruction for the Patients with Locally Advanced Esophageal Carcinoma with the HinotoriTM Surgical Robot System
Acronym
HINOTORI trial
Scientific Title
Feasibility study of Robot-Assisted Esophagectomy and Robot-Assisted Gastric Tube Reconstruction for the Patients with Locally Advanced Esophageal Carcinoma with the HinotoriTM Surgical Robot System
Scientific Title:Acronym
HINOTORI trial
Region
| Japan |
Condition
Condition
Esophageal Carcinoma
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study is an interventional trial targeting patients with clinical stage I, II, III (excluding T4), or IV esophageal cancer (limited to supraclavicular lymph node metastasis, excluding T4). The aim is to demonstrate the non-inferiority of the safety and short-term outcomes of robot-assisted esophagectomy and robot-assisted gastric tube reconstruction using the hinotori Surgical Robot System compared to the DaVinci Surgical System.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary endpoint: Incidence rate of recurrent laryngeal nerve palsy of CTCAE v5.0 Grade 1 or higher / Clavien-Dindo classification Grade I or higher
Key secondary outcomes
Secondary endpoints: Operation time, amount of blood loss, incidence rate of intraoperative adverse events, rate of curative resection, incidence rate of postoperative pneumonia, incidence rate of anastomotic leakage, incidence rate of postoperative complications, length of postoperative hospital stay, and cost per surgery.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Robot-assisted esophagectomy and gastric tube reconstruction will be performed using the hinotori Surgical Robot System.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Disease: The patient has histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, basaloid squamous cell carcinoma, or adenocarcinoma of the esophagus (biopsy of secondary lesions is not required but must confirm the same diagnosis if performed).
2.Extent of Disease: The lesion is located in the thoracic esophagus or Siewert type II/III gastroesophageal junction (UICC-TNM 8th edition, stage I-IV, excluding T4).
3. Age: The patient is between 20 and 80 years old at enrollment.
4.Performance Status: ECOG performance status of 0 or 1.
5.Measurability: Measurable lesions are not required.
6.Prior Treatment: No prior esophageal cancer treatment except for non-curative EMR/ESD or preoperative chemotherapy.
7.Prior/Concomitant Disease: No prior chemotherapy/radiotherapy for other cancers, except endocrine therapy for prostate or breast cancer. No history of right thoracotomy or major left lung resection (pneumothorax surgery allowed).
8.Prior/Concomitant Treatment: None specified.
9.Laboratory Tests: Blood tests within 14 days before enrollment must meet the following:
WBC greater than or equal to 3000 per cubic millimeter
Platelets greater than or equal to 100,000 per cubic millimeter
Hemoglobin greater than or equal to 10.0 grams per deciliter (no transfusions in 14 days)
Total bilirubin less than or equal to 1.5 milligrams per deciliter
AST and ALT less than or equal to 100 units per liter
Creatinine less than or equal to 1.5 milligrams per deciliter
10.Consent: Written informed consent obtained for trial participation.
Key exclusion criteria
1.The patient has active double/multiple cancers (synchronous or metachronous with a disease-free interval <5 years), excluding certain early-stage cancers or fully resected cases with a high survival rate.
2.The patient has a fever of 38 degrees Celsius or higher at registration.
3.The patient has a mental illness or psychiatric symptoms that hinder trial participation.
4.The patient is receiving ongoing systemic steroids or immunosuppressants.
5.The patient has uncontrolled diabetes despite medication.
6.The patient has uncontrolled hypertension.
7.The patient has unstable angina or a recent history of myocardial infarction (within 6 months).
8.The patient has uncontrolled valvular disease or cardiomyopathy.
9.The patient has interstitial pneumonia, pulmonary fibrosis, or severe emphysema diagnosed by CT.
10.Other conditions deemed unsuitable by the investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Daiko |
Organization
National Cancer Center Hospital
Division name
Department of Esophageal Surgery
Zip code
104-0045
Address
5-5-1 Tsukiji, Chuo-ku, Tokyo
TEL
0335422511
hdaiko@ncc.go.jp
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Igaue |
Organization
National Cancer Center Hospital
Division name
Department of Esophageal Surgery
Zip code
104-0045
Address
5-5-1 Tsukiji, Chuo-ku, Tokyo
TEL
0335422511
Homepage URL
sigaue@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
No funding provided
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
SYSMEX CORPORATION
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center IRB
Address
5-5-1 Tsukiji, Chuo-ku, Tokyo
Tel
0335422511
irst@ml.res.ncc.go.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 | 10 | 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
| 2023 | Year | 12 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 08 | Month | 22 | Day |
Last modified on
| 2024 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063212
