UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029227 |
|---|---|
| Receipt number | R000033408 |
| Scientific Title | A randomized study of a 3D-HD or a 2D-4K laparoscopic surgery for gastric cancer. |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2021/10/07 17:43:33 |
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Basic information
Public title
A randomized study of a 3D-HD or a 2D-4K laparoscopic surgery for gastric cancer.
Acronym
Laparoscopic surgery for gastric cancer (3D-HD vs 2D-4K)
Scientific Title
A randomized study of a 3D-HD or a 2D-4K laparoscopic surgery for gastric cancer.
Scientific Title:Acronym
Laparoscopic surgery for gastric cancer (3D-HD vs 2D-4K)
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the usefulness of a 3D-HD laparoscopy for laparoscopic gastrectomy compared to a 2D-4K laparoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The operative time (Overall operative time, Partly operative time for each technical part)
Key secondary outcomes
A number of dissected lymph nodes, Blood loss, A number of bleeding, The rate of infectious complication (pancreatic fistula, abdominal abscess), The postoperative days
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
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
3D-HD laparoscopy (1 year)
Interventions/Control_2
2D-4K laparoscopy (1 year)
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) Pathologically diagnosed as gastric cancer
2) T1-T4aN0 or T1-T1aN(+) according to Japanese Classification of Gastric Carcinoma the 14th edition. (N(+) as N1 according to Japanese Classification of Gastric Carcinoma the 13th edition.)
3) Indication of curative resection by distal gastrectomy or total gastrectomy
4) No invading the esophagus or duodenum.
5) 20 years-old or above, 79 years-old or below
6) Performance status (ECOG) 0 or 1
7) BMI(Body mass index) <30
8) The most recent blood examination satisfies following items:
(1) WBC: 3,000/mm3 or above
(2) PLT: 100,000/mm3 or above
(3) T-BIL: 2.0 mg/dL or below
(4) AST(GOT): 100 IU/L or below
(5) ALT(GPT): 100 IU/L or below
(6) CRE: 1.5 mg/dL or below
9) Getting informed consent from the patient in writing
Key exclusion criteria
1) Infectious disease required systemic therapy
2) Body temperature: 38 degrees or above
3) Pregnant, possibility in pregnancy, Within postpartum 28 days or lactating
4) Difficult to cooperate in the trial for psychiatric reasons
5) Administration of steroids or immunosuppressants
6) History of unstable angina pectoris or within six month after acute myocardial infarction
7) Uncontrolled hypertension
8) Uncontrolled diabetes regardless of administration of insulin
9) Respiratory disease receiving continuous oxygen inhalation
10) Surgery for remnant gastric cancer, esophagogastric junction cancer or another simultaneous disease (without cholecystectomy)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Kanaji |
Organization
Graduate School of Medicine, Kobe University
Division name
Division of Gastroenterology, Department of Surgery
Zip code
6500017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-5925
kanashin@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Harada |
Organization
Graduate School of Medicine, Kobe University
Division name
Division of Gastroenterology, Department of Surgery
Zip code
6500017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-5925
Homepage URL
htharada@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of Gastroenterology, Department of Surgery, Graduate School of Medicine, Kobe 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
Kobe University Hospital Institutional Review Board
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo
Tel
078-382-5925
kainyu@med.kobe-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
神戸大学医学附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/34458930/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/34458930/
Number of participants that the trial has enrolled
42
Results
There were no significant differences in surgical outcomes between the two groups. However, video analysis of surgeries revealed a significantly shortened median operative time (18 vs. 25 min, P=0.04) in the suturing step with 3-D/HD; the median number of camera cleaning procedures during suprapancreatic lymph node dissection was significantly lower with 2-D/4 K than with 3-D/HD (n=4.4 vs. 2.8, P=0.02).
Results date posted
| 2021 | Year | 10 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The patients were diagnosed as gastric cancer and considered to be performed laparoscopic gastrectomy for curative resection in our institution, from April 2018 to August 2019.
Participant flow
50 patients were randomly classified into two groups based on the imaging technology (3-D/HD group=25, 2-D/4 K=25). After excluding eight patients based on laparoscopic findings, 42 patients were analyzed (3-D/HD group=21, 2-D/4 K=21).
Adverse events
There were three cases in the 3D/HD group and six cases in the 2D/4K group with postoperative complications of grade II or higher according to the Clavien-Dindo classification.
Outcome measures
The primary study endpoint was the operative time (overall operative time, partial operative time for each technical step). In contrast, the secondary endpoints were the number of dissected lymph nodes, blood loss, the amount of bleeding, incidence rate of postoperative infectious complications (pancreatic fistula and abdominal abscess), and postoperative hospital stay. Postoperative morbidity was described according to the Clavien-Dindo classification.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 21 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 21 | Day |
Last modified on
| 2021 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033408
