UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057158 |
|---|---|
| Receipt number | R000065084 |
| Scientific Title | Feasibility and safety of a novel thin therapeutic endoscope combination surgery for gastrointestinal tumors: A retrospective cohort study |
| Date of disclosure of the study information | 2025/02/27 |
| Last modified on | 2025/04/11 23:25:13 |
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Basic information
Public title
Pilot clinical evaluation of a novel dual-operator endoscopic technique (TECS) for gastrointestinal tumor resection: Technical feasibility, safety, and learning curve analysis
Acronym
TECS study
Scientific Title
Feasibility and safety of a novel thin therapeutic endoscope combination surgery for gastrointestinal tumors: A retrospective cohort study
Scientific Title:Acronym
TECS study
Region
| Japan |
Condition
Condition
Gastrointestinal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to evaluate the clinical efficacy and safety of TECS, a treatment using two thin-diameter therapeutic endoscopes devised at our facility, through a retrospective analysis of patients who underwent the procedure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome measure was defined as the success rate of the procedure, which was defined as the completion of the treatment procedure from start to finish using only TECS.
Key secondary outcomes
Secondary outcomes included the en bloc resection rate, procedure time, resection speed, and rate of adverse events.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients included in the study were aged 18 years or older, had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, and had been diagnosed with an epithelial tumor of the stomach or large intestine deemed suitable for ESD based on preoperative endoscopic evaluation. The TECS eligibility criteria were the same as those for ESD, which were based on the treatment guidelines for gastrointestinal cancer in Japan [12,13]. The size, shape, location, and fibrosis of the tumor were not taken into account. Only patients who received a full explanation of the procedure, its associated risks, and alternative treatment options and who provided written informed consent, were included in the study.
Key exclusion criteria
Patients were excluded if they had incomplete clinical records regarding preoperative assessment, procedural details, or postoperative course; if there was a discrepancy between the endoscopic diagnosis and the final pathological findings (e.g., no tumor identified); if adequate sedation could not be achieved; or if they declined to provide written informed consent despite receiving a full explanation of the procedure and associated risks.
Target sample size
43
Research contact person
Name of lead principal investigator
| 1st name | Takuma |
| Middle name | |
| Last name | Okamura |
Organization
Nagasaki Harbor Medical Center
Division name
gastroenterology
Zip code
850-8555
Address
6-39 Shinchi-cho, Nagasaki City, Nagasaki
TEL
0958223251
taku.okamu1002@gmail.com
Public contact
Name of contact person
| 1st name | Takuma |
| Middle name | |
| Last name | Okamura |
Organization
Nagasaki Harbor Medical Center
Division name
gastroenterology
Zip code
850-8555
Address
6-39 Shinchi-cho, Nagasaki City, Nagasaki
TEL
0958223251
Homepage URL
taku.okamu1002@gmail.com
Sponsor or person
Institute
Nagasaki Harbor Medical Center
Institute
Department
Personal name
Takuma Okamura
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
Nagasaki Minato Medical Center Research and Development Center
Address
6-39 Shinchi-cho, Nagasaki City, Nagasaki
Tel
0958223251
kenkyu@ncho.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 | 02 | Month | 27 | 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
44
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
Completed
Date of protocol fixation
| 2025 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Outcomes and definitions
The primary outcome measure was defined as the success rate of the procedure, which was defined as the completion of the treatment procedure from start to finish using only TECS. Secondary outcomes included the en bloc resection rate, procedure time, resection speed, and rate of adverse events. En bloc resection was defined as the removal of the lesion as a single mass. The procedure time was measured from the start of the peripheral incision to the end of resection. Resection speed was calculated by dividing the approximated ellipsoidal surface area of the resected specimen (using its long and short diameters) by the procedure time. Adverse events included intraoperative perforation,post operative bleeding, or postoperative perforation.
Statistical analysis
Descriptive statistics were used to summarize the data. All statistical analyses were performed using Bell Curve for Excel. Continuous variables are expressed as means standard deviations or medians with interquartile ranges (IQRs), depending on the data distribution. Categorical variables are presented as percentages.
Management information
Registered date
| 2025 | Year | 02 | Month | 27 | Day |
Last modified on
| 2025 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065084
