UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Helicobacter pylori eradication therapy in gastric cancer patients who undergo pylorogastrectomy
Title of the study (Brief title)	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	Naoki Hiki
Organization	The Cancer Institute Hospital of JFCR
Division name	Gastroenterological Surgery
Address	3-10-6, Ariake, Koto-ku, Tokyo
TEL	03-3520-0111
Email

Public contact
Name of contact person	Naoki Hiki
Organization	The Cancer Institute Hospital of JFCR
Division name	Gastroenterological Surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/26141464?dopt=Citation
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.
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/icdr_e/ctr_view.cgi?recptno=R000003250