UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051052 |
|---|---|
| Receipt number | R000058117 |
| Scientific Title | Randomized controlled phase II trial to evaluate non-inferiority of using linear stapling device with bioabsorbable polyglycolic acid sheet to reinforcement with buried suture for duodenal stump in robotic gastric cancer surgery |
| Date of disclosure of the study information | 2023/05/15 |
| Last modified on | 2023/11/12 12:38:57 |
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Basic information
Public title
Randomized controlled phase II trial to evaluate non-inferiority of using linear stapling device with bioabsorbable polyglycolic acid sheet to reinforcement with buried suture for duodenal stump in robotic gastric cancer surgery
Acronym
Randomized controlled phase II trial to evaluate non-inferiority of using linear stapling device with bioabsorbable polyglycolic acid sheet to reinforcement with buried suture for duodenal stump in robotic gastric cancer surgery
Scientific Title
Randomized controlled phase II trial to evaluate non-inferiority of using linear stapling device with bioabsorbable polyglycolic acid sheet to reinforcement with buried suture for duodenal stump in robotic gastric cancer surgery
Scientific Title:Acronym
R-duodenal stump study
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the non-inferiority of using linear stapling device with bioabsorbable polyglycolic acid sheet to reinforcement with buried sutures for duodenal stump in robotic gastric cancer surgery
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of duodenal stump leakage after gastrectomy
Key secondary outcomes
1. operative time, 2. estimated blood loss, 3. incidence of postoperative complication, 4. hemostasis at duodenal stump, 5. injury at duodenal stump, 6. postoperative hospital stay
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
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Reinforcement with buried suture for duodenal stump in robotic gastrectomy (distal or total gastrectomy) with R-en-Y reconstruction.
Interventions/Control_2
Using linear stapling device with bioabsorbable polyglycolic acid sheet for duodenal transection in robotic gastrectomy (distal or total gastrectomy) with R-en-Y reconstruction.
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) Histologically proven gastric adenocarcinoma by endoscopic biopsy.
2) Distal or total gastrectomy is required for radical resection, and R0 surgery is feasible.
3) R-en-Y reconstruction is planned.
4) The diagnosis of clinical stage I, II or III.
5) No invasion to esophagus.
6) No invasion to duodenum.
7) Not a stump cancer of stomach.
8) Adequate oral intake and no need for preoperative fluids.
9) No combined resection other than the gallbladder.
10) Aged 20 years old or older.
11) Eastern Cooperative Oncology Group performance status of 0 or 1.
12) No prior abdominal radiotherapy for any malignancies. History of chemotherapy and/or endocrine therapy is eligible.
13) No history of upper abdominal surgery except laparoscopic cholecystectomy.
14) Body mass index (BMI) is less than 30.
15) Adequate organ functions defined as;
i) WBC of 3,000/mm3 or more
ii) Platelet count 100,000/mm3 or more
iii) AST and/or ALT of 100 IU/L or less
iv) T.Bil of 2.0 mg/dL or less
v) Creatinine of 1.5 mg/dL or less
16) Written informed consent.
Key exclusion criteria
1) Synchronous or metachronous (within 5 years) malignancies.
2) Infectious disease requiring systemic treatment.
3) Body temperature of 38 degrees Celsius or higher.
4) During pregnancy, within 28 days postpartum, or during lactation.
5) Severe mental disease.
6) Receiving continuous systemic corticosteroid or immunosuppressant treatment.
7) History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration.
8) Poorly controlled valve disease, dilated or hypertrophic cardiomyopathy.
9) HIV antibody positive.
10) Uncontrolled diabetes mellitus.
11) Respiratory disease requiring continuous oxygen administration.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Hikage |
Organization
Iwate Prefectural Isawa Hospital
Division name
Division of Surgery
Zip code
023-0864
Address
61 Ryugababa, Mizusawa-ku, Oshu-shi, Iwate, Japan
TEL
0197-24-4121
mhikage@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Hikage |
Organization
Iwate Prefectural Isawa Hospital
Division name
Division of Surgery
Zip code
023-0864
Address
61 Ryugababa, Mizusawa-ku, Oshu-shi, Iwate, Japan
TEL
0197-24-4121
Homepage URL
mhikage@med.tohoku.ac.jp
Sponsor or person
Institute
Iwate Prefectural Isawa Hospital
Institute
Department
Personal name
Funding Source
Organization
self-funding
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
Iwate Prefectural Isawa Hospital Institutional Review Board
Address
61 Ryugababa, Mizusawa-ku, Oshu-shi, Iwate, Japan
Tel
0197-24-4121
isawasenmoni@gmail.com
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
| 2023 | Year | 05 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 05 | 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
| 2023 | Year | 05 | Month | 13 | Day |
Last modified on
| 2023 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058117
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/11/12 | RobotDSR_protocol_ver1.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2023/11/12 | CRF_8_治療終了評価.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/11/12 | CRF_1_B0001.docx |
