UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051294 |
|---|---|
| Receipt number | R000058497 |
| Scientific Title | Safety and efficacy of staging laparoscopy for the diagnosis of gastric cancer recurrence after gastrectomy: observational study |
| Date of disclosure of the study information | 2023/06/08 |
| Last modified on | 2023/09/08 17:40:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Safety and efficacy of staging laparoscopy for the diagnosis of gastric cancer recurrence after gastrectomy: observational study
Acronym
staging laparoscopy for the diagnosis of gastric cancer recurrence after gastrectomy: observational study
Scientific Title
Safety and efficacy of staging laparoscopy for the diagnosis of gastric cancer recurrence after gastrectomy: observational study
Scientific Title:Acronym
staging laparoscopy for the diagnosis of gastric cancer recurrence after gastrectomy: observational study
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify safety and efficacy of staging laparoscopy for the diagnosis of gastric cancer recurrence after gastrectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the percentage of post-operative complication over Clavian-Dindo Grade3
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
>over 20-year-old
>after gastrectomy for gastric cancer
>histopathological diagnosis of gastric adenocarcinoma
>either 1 or 2 or 3
1:suspicous of peritoneal dissemination (elevation of tumor marker, hydronephrosis, bowel obstraction, increased ascites, etc.) without apparent change of imaging examination
2:under consideration of finishing chemotherapy after R1 resection (CY1 or few P1)
3:Advanced gastric cancer over pStage3 with recommendation of checking peritoneal dissemination
>Without diagnosis of metastatic tumor by CT scan other than peritoneal dissemination
>Any performance status (ECOG) is eligible.
>Written informed consent to participate in this study has been obtained.
Key exclusion criteria
>Patients with a general condition that makes it difficult to undergo staging laparoscopy under general anesthesia
>Cases in which staging laparoscopy is judged inappropriate by the attending physician
Target sample size
50
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 | 08 | 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 | 04 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 14 | Day |
Last follow-up date
| 2028 | Year | 12 | 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 | 08 | 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=R000058497
