UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020280 |
|---|---|
| Receipt number | R000023413 |
| Scientific Title | Investigation of H.pylori prevalence and its spontaneous eradication rate in gastric cancer patients for gastrectomy: A prospective study |
| Date of disclosure of the study information | 2015/12/19 |
| Last modified on | 2025/01/27 10:46:23 |
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Basic information
Public title
Investigation of H.pylori prevalence and its spontaneous eradication rate in gastric cancer patients for gastrectomy: A prospective study
Acronym
A prospective study of H.pylori prevalence and spontaneous eradication in patients for gastrectomy
Scientific Title
Investigation of H.pylori prevalence and its spontaneous eradication rate in gastric cancer patients for gastrectomy: A prospective study
Scientific Title:Acronym
A prospective study of H.pylori prevalence and spontaneous eradication in patients for gastrectomy
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the prevalence of H.pylori in gastric cancer patients and its spontaneous eradication rate after gastrectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Spontaneous eradication rate of H. pylori one year after gastrectomy
Key secondary outcomes
Prevalence of H. pylori before gastrectomy, Overall survival, Relapse free survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
H.pylori test before gastrectomy and follow-up one year after gastrectomy for H. pylori positive patients
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)Pathologically diagnosed as primary gastric adenocarcinoma
2)Planed to complete resection by distal gastrectomy or proximal gastrectomy
3)20 years old or older at the enrollment
4)Document of agreement with eorollment in person
Key exclusion criteria
1)History of gastrectomy
2)Histry of H. pylori treatment
3)Case judged as ineligible by attending physicia
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Doki |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
565-0871
Address
2-2-E2, Yamadaoka, Suita, Osaka
TEL
+81-6-6879-3251
ydoki@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takahashi |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
565-0871
Address
2-2-E2, Yamadaoka, Suita, Osaka
TEL
81-6-6879-3251
Homepage URL
ttakahashi2@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Clinical Study Group of Osaka University
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
Osaka University Hospital Institutional Review Board
Address
2-15, Yamadaoka, Suita, Osaka
Tel
81-6-6210-8289
rinri@hp-crc.med.osaka-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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 19 | Day |
Related information
URL releasing protocol
https://doi.org/10.1002/ags3.12860
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1002/ags3.12860
Number of participants that the trial has enrolled
1265
Results
A total of 1247 patients were included in this study. The preoperative H. pylori status was positive in 756 patients and negative in 491. Seventy-nine of the negative patients had an eradication history, totaling 835 (67%) patients preoperatively infected with H. pylori. The infection status of 541 patients was examined 1 year postoperatively; 285 were negative, with a 52.7% spontaneous eradication rate. Spontaneous eradication was significantly higher in male and older patients (>70 years).
Results date posted
| 2025 | Year | 01 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The eligibility criteria were as follows: (i) patients planned to undergo R0 gastrectomy (distal or proximal gastrectomy) for histologically proven primary GC with no clinical distant metastasis, and (ii) age >20 years at enrollment. The exclusion criterion was a history of gastrectomy. All the patients provided written informed consent and were enrolled preoperatively. The final extent of gastric resection depended on the intraoperative judgment of the attending surgeons in clinical practice. Reconstruction methods after gastrectomy were not specified. Gastrectomy was performed using either open laparotomy or laparoscopy.
Participant flow
All patients were tested using one method for H. pylori preoperatively. All established H. pylori infection tests, including a blood test measuring antibodies to H. pylori, rapid urease test, histopathology test, urea breath test, stool antigen test, and culture method were permitted. They were instructed to discontinue PPI medication for 2 weeks before the H. pylori test. Patients for H. pylori positive was inhibited to the eradiation after surgery for 1 year and tested again by any method 1 year after surgery. Blood test measuring antibodies may take more than 1 year to become negative after successful eradication, so we recommended not to use this method.
Adverse events
None
Outcome measures
The primary endpoint was the spontaneous eradication rate of H. pylori 1 year after surgery. The secondary endpoints were the prevalence of H. pylori infection in patients who underwent distal or proximal gastrectomy, overall survival, and relapse-free survival. The spontaneous eradication of H. pylori was defined as cases in which patients who had a positive test before surgery, regardless of preoperative eradication history, had a negative test A1 year after surgery. The prevalence of H. pylori infection was calculated considering all patients with a history of eradication as positive, regardless of the results of H. pylori tests.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 2015 | Year | 12 | Month | 19 | Day |
Last modified on
| 2025 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023413
