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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002669
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute The Cancer Institute Hospital of JFCR, Gastroenterological Surgery
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003250

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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