UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002669 |
|---|---|
| Receipt number | R000003250 |
| Scientific Title | Helicobacter pylori eradication therapy in gastric cancer patients who undergo pylorogastrectomy |
| Date of disclosure of the study information | 2009/11/01 |
| Last modified on | 2018/05/08 16:42:02 |
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Basic information
Public title
Helicobacter pylori eradication therapy in gastric cancer patients who undergo pylorogastrectomy
Acronym
Helicobacter pylori eradication therapy in gastric cancer patients who undergo pylorogastrectomy
Scientific Title
Helicobacter pylori eradication therapy in gastric cancer patients who undergo pylorogastrectomy
Scientific Title:Acronym
Helicobacter pylori eradication therapy in gastric cancer patients who undergo pylorogastrectomy
Region
| Japan |
Condition
Condition
Gastric cancer patients who undergo pylorogastrectomy
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the efficacy of triple therapy for Helicobacter pylori eradication in gastric patients who undergo pylorogastrectomy:A randomized trial,preoperative versus postoperative
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Eradication rate for Helicobacter pylori
Key secondary outcomes
symptoms
findings of upper gastrointestinal endoscopy
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
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Preoperative Helicobacter pylori eradication triple therapy
Interventions/Control_2
Postoperative Helicobacter pylori eradication triple therapy
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
Gastric cancer patients who undergo pylorogastrectomy
Key exclusion criteria
Recurrent gastric cancer,Previous gastric surgery,stage4,underwent total gastrectomy,history of H.pylori eradication therapy,contraindication of H.pylori triple therapy
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Hiki |
Organization
The Cancer Institute Hospital of JFCR
Division name
Gastroenterological Surgery
Zip code
Address
3-10-6, Ariake, Koto-ku, Tokyo
TEL
03-3520-0111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Hiki |
Organization
The Cancer Institute Hospital of JFCR
Division name
Gastroenterological Surgery
Zip code
Address
3-10-6, Ariake, Koto-ku, Tokyo
TEL
03-3520-0111
Homepage URL
Sponsor or person
Institute
The Cancer Institute Hospital of JFCR, Gastroenterological Surgery
Institute
Department
Personal name
Funding Source
Organization
The Cancer Institute Hospital of JFCR, Gastroenterological Surgery
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
Address
Tel
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
| 2009 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/26141464?dopt=Citation
Number of participants that the trial has enrolled
Results
BACKGROUND:
The Maastricht, Asia-Pacific consensus guidelines strongly recommend eradication of Helicobacter pylori in patients who have a history of gastric cancer. This open-label, single-center, randomized controlled trial was conducted to investigate the appropriate timing of eradication for patients undergoing gastrectomy.
STUDY DESIGN:
One hundred and fifty patients scheduled to undergo gastrectomy were allocated to either a preoperative or a postoperative group. The eradication regimen was a common triple therapy: rabeprazole, amoxicillin, and clarithromycin [corrected]. Patients in the preoperative group were treated with the regimen, followed by surgery, and patients in the postoperative group were treated after postoperative day 8. The primary end point was the proportion of patients achieving successful eradication in the remnant stomach. The definition of successful eradication was negativity in both the C13 urea breath test and for the antigen in feces at 6 months after surgery.
RESULTS:
Eight patients were excluded, and the remaining one hundred and forty-two, 70 in the preoperative group and 72 in the postoperative group, were included on an intention to treat basis. The procedures used were gastrectomy with Billroth I, Roux-en-Y, and pylorus-preserving gastrectomy in 18, 70, and 57 patients, respectively. The proportion of patients showing successful eradication hardly differed between the 2 groups, 68.6% vs 69.4% (p = 1.000) in the pre- and postoperative groups, respectively. Subgroup analysis also demonstrated no significant difference among the reconstruction methods used.
CONCLUSIONS:
Preoperative H pylori eradication therapy for gastric cancer patients scheduled for gastrectomy is not necessary, regardless of the planned reconstruction procedure.
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
Completed
Date of protocol fixation
| 2009 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 05 | Month | 06 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 10 | Month | 26 | Day |
Last modified on
| 2018 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003250
