UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051321 |
|---|---|
| Receipt number | R000058508 |
| Scientific Title | Safety and efficacy of adhesion barrier products on the inferor surface of the liver in laparoscopic gastrectomy |
| Date of disclosure of the study information | 2023/06/11 |
| Last modified on | 2023/09/08 17:41:51 |
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Basic information
Public title
Safety and efficacy of adhesion barrier products on the inferor surface of the liver in laparoscopic gastrectomy
Acronym
Safety and efficacy of adhesion barrier products on the inferor surface of the liver in laparoscopic gastrectomy
Scientific Title
Safety and efficacy of adhesion barrier products on the inferor surface of the liver in laparoscopic gastrectomy
Scientific Title:Acronym
Safety and efficacy of adhesion barrier products on the inferor surface of the liver in laparoscopic gastrectomy
Region
| Japan |
Condition
Condition
gastric cancer or esophagogastric junction cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the safety and efficacy of adhesion barrier products on the inferior surface of the liver in laparoscopic gastrectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence rate of postoperative intra-abdominal infections (anastomotic leakage, pancreatic fistula, intra-abdominal abscess) of Clavien-Dindo classification Grade II or higher
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients aged 20 years or older at the time of informed consent.
2)Histologically diagnosed with cancer
3) Patients with ECOG Performance Status of 0-1.
4)Patients who have preserved heart, lung, liver, kidney and bone marrow functions and who meet all of the following laboratory test values.
a. Renal function:
BUN less than 1.5 times the facility's upper limit of normal values
Serum creatinine level less than 1.5 times the facility's upper limit of normal values
b. Liver function:
AST (GOT) less than 1.5 times the facility's upper limit of normal values
ALT (GPT) less than 1.5 times the facility's upper limit of normal values
Serum total bilirubin level less than 1.5 times the facility's upper limit of normal values
c. Blood:
Neutrophils 1,500/mm3 or more
Platelet count 100,000/mm3 or more
Hb 8.0 g/dL or more
d. Cardiac function
Electrocardiogram: no serious abnormalities
e. Lung function
Pulmonary function: arterial blood oxygen saturation (Sp02) more than 94% (without oxygen administration)
5) Patients with no other active double cancers (including hematologic malignancies).
6)Patients who have been informed of their disease name and condition, who have received an explanation of this study, and who are able to obtain written consent after understanding the content.
Key exclusion criteria
1) Patients with uncontrolled infections (including active tuberculosis)
2) Patients with a history of hypersensitivity to anti-adhesion agents
3) Pregnant women, lactating women, or patients who may be pregnant.
4) Patients with uncontrolled diabetes
5) Patients who have a history of upper abdominal surgery (including laparoscopic surgery) in the past, patients who have a history of open surgery
6) Patients who are currently using or have a history of long-term use of steroid hormones
7) Other patients who are judged to be ineligible by the principal investigator or co-investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Omori |
Organization
Osaka International Cancer Institute
Division name
Gastroenterological Surgery
Zip code
5418567
Address
3-1-69 Otemae, Chuo-ku, Osaka
TEL
+81-6-6945-1181
takeshi.oomori@oici.jp
Public contact
Name of contact person
| 1st name | Yasunori |
| Middle name | |
| Last name | Masuike |
Organization
Osaka International Cancer Institute
Division name
Gastroenterological Surgery
Zip code
548567
Address
3-1-69 Otemae, Chuo-ku, Osaka
TEL
+81-6-6945-1181
Homepage URL
yasunori.masuike@oici.jp
Sponsor or person
Institute
Osaka International Cancer Institute
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
Clinical Research Center, Osaka International Cancer Institute
Address
3-1-69 Otemae, Chuo-ku, Osaka
Tel
+81-6-6945-1181
rinri01@opho.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
| 2023 | Year | 06 | Month | 11 | 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
| 2021 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 31 | 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
not particular
Management information
Registered date
| 2023 | Year | 06 | Month | 11 | Day |
Last modified on
| 2023 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058508
