Helicobacter Pylori InfectionNCT00441831
The Revolutions of Helicobacter Pylori Infection, Bacterial Density, and Histological Features After Antrectomy
An observational study of Helicobacter Pylori Infection and Peptic Ulcer, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
Helicobacter pylori (HP) is a gram-negative bacillus responsible for one of the most common infections found in humans worldwide. By the early-to-mid 1990s, further evidence emerged supporting the link between the chronic gastritis of HP infection and malignancy in adults, specifically gastric lymphoma and… Read more about this study
- Who is it for?
- Ages 15 to 95 years
- Conditions the study is for
- Helicobacter Pylori Infection, Peptic Ulcer, Bile Reflux
- How many people
- 65 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2007to Feb 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 95 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with previous distal gastrectomy
Who may be able to join
- Previous distal gastrectomy
Who cannot join
- Post HP eradication therapy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Division of Gastroenterology, Department of Internal Medicine, Mackay Memorial Hospital
Taipei
Ming-Jen Chen, M.D., M.S., 886-2-25433535 ext. 2260, mingjen.ch@msa.hinet.net
Ming-Jen Chen, M.D., M.S.
About this study
Helicobacter pylori (HP) is a gram-negative bacillus responsible for one of the most common infections found in humans worldwide. By the early-to-mid 1990s, further evidence emerged supporting the link between the chronic gastritis of HP infection and malignancy in adults, specifically gastric lymphoma and adenocarcinoma. The potential of HP eradication for the prevention of gastric cancer was underlined. At the national consensus meeting held in Brussels in 1998, HP eradication was strongly recommended in past or current peptic ulcer diseases, regardless of activity, complication and post endoscopic resection of early cancer. Some patients received gastric surgery due to the complications of peptic ulcer such as bleeding or perforation in the pre-HP eradication era. Their HP infection status was not surveyed and unknown at the time. Afterward, some of them were not suggested to receive an eradication therapy and recovered from the operative procedure. According to the consensus to treat HP for a purpose to reduce the risk of gastric cancer, these patients were still under risk. There have been only a few surveys on the prevalence of persistent HP infection in patients who have undergone surgery. The aim of the study was to evaluate the prevalence and histological features of HP infection after a time course of partial distal gastric surgery.
Read the detailed description
The eradication of H pylori is known to reduce the recurrence rate of peptic ulcer and gastric inflammation. But it is still not clear about the prevalence of HP infection in patients after surgical interventions when the micro-environment had been changed. Since biliary enterogastric reflux is suggested to inhibit the growth of HP, we will investigate in a prospective study the effect of partial gastrectomy on the influence of HP infection incidence.
Patients with previous distal gastrectomy will be prospectively evaluated as study group. Same number of patients with the same indication of endoscopy evaluations and without previous gastrectomy will be established as a normal control group for H pylori infection rate comparison. All patients in study and control groups who had previously received H pylori eradication therapy will be excluded. Three gastric biopsy specimens were collected from each patient for histological analysis. Patients with a pre-operative biopsy, operative specimen revealing H pylori colonization or a positive serum H pylori IgG will be indicated previous H pylori infection and will be assessed the percentage of spontaneous clearance of HP infection. A positive bile staining will indicate biliary enterogastric reflux. This assessment will be made by two investigators, and disagreements will be resolved by joint discussion to reach a consensus. Tissue sections stained with hematoxylin and eosin and the Giemsa stain will be examined by pathologist who was unaware of the endoscopy findings. Density of HP in the tissue and histological gastritis activity and intestinal metaplasia will be graded as normal (0), mild (1), moderate (2) and severe (3) based on the Sydney system. Follicular gastritis will be based on the absence (0) or presence (1) of lymphoid follicules and lymphoid with germinal center (2).
The primary end point will be the change of infection rate on HP after distal gastrectomy procedure comparing the normal control. The secondary end point will assess the correlation between the duration of the antrectomy, the operative procedure, the severity of bile reflux with the inhibition of HP growth. Finally, this study will be base on histopathological features with the density of HP, the grading of gastritis activity, intestinal metaplasia and follicular gastritis.
- Conditions
- Helicobacter Pylori Infection, Peptic Ulcer, Bile Reflux, Gastritis
- Keywords
- Helicobacter pylori infection, peptic ulcer disease, distal partial gastrectomy, bile reflux, gastritis, gastrectomy
- Medical subject headings
- Peptic Ulcer, Bile Reflux, Gastritis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2007 (estimated)
- Study startFeb 2007
- Study completionFeb 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ming-Jen Chen, M.D.,M.S., Principal investigator, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00441831
- Sponsor's protocol ID
- MMH-I-S-261
- Status last verified
- Feb 2009
- First submitted
- 27 Feb 2007
- Last updated
- 5 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fukuhara K, Osugi H, Takada N, Takemura M, Lee S, Taguchi S, Kaneko M, Tanaka Y, Fujiwara Y, Nishizawa S, Kinoshita H. Duodenogastric reflux eradicates Helicobacter pylori after distal gastrectomy. Hepatogastroenterology. 2004 Sep-Oct;51(59):1548-50.
PubMed 15362798Huang WH, Wang HH, Wu WW, Lai HC, Hsu CH, Cheng KS. Helicobacter pylori infection in patients with ulcer recurrence after partial gastrectomy. Hepatogastroenterology. 2004 Sep-Oct;51(59):1551-3.
PubMed 15362799Malfertheiner P, Megraud F, O'Morain C, Bazzoli F, El-Omar E, Graham D, Hunt R, Rokkas T, Vakil N, Kuipers EJ. Current concepts in the management of Helicobacter pylori infection: the Maastricht III Consensus Report. Gut. 2007 Jun;56(6):772-81. doi: 10.1136/gut.2006.101634. Epub 2006 Dec 14.
PubMed 17170018Johannesson KA, Hammar E, Stael von Holstein C. Mucosal changes in the gastric remnant: long-term effects of bile reflux diversion and Helicobacter pylori infection. Eur J Gastroenterol Hepatol. 2003 Jan;15(1):35-40. doi: 10.1097/00042737-200301000-00007.
PubMed 12544692
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Revolutions of Helicobacter Pylori Infection, Bacterial Density, and Histological Features After Antrectomy
- ClinicalTrials.gov ID
- NCT00441831
- Acronym / sponsor ID
- MMH-I-S-261
- Conditions
- Helicobacter Pylori Infection, Peptic Ulcer, Bile Reflux, Gastritis
- Keywords
- Helicobacter pylori infection, peptic ulcer disease, distal partial gastrectomy, bile reflux, gastritis, gastrectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- Feb 2007
- Study completion
- Feb 2008 (estimated)
- First posted
- 1 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Helicobacter pylori (HP) is a gram-negative bacillus responsible for one of the most common infections found in humans worldwide. By the early-to-mid 1990s, further evidence emerged supporting the link between the chronic gastritis of HP infection and malignancy in adults, specifically gastric lymphoma and adenocarcinoma. The potential of HP eradication for the prevention of gastric cancer was underlined. At the national consensus meeting held in Brussels in 1998, HP eradication was strongly recommended in past or current peptic ulcer diseases, regardless of activity, complication and post endoscopic resection of early cancer. Some patients received gastric surgery due to the complications of peptic ulcer such as bleeding or perforation in the pre-HP eradication era. Their HP infection status was not surveyed and unknown at the time. Afterward, some of them were not suggested to receive an eradication therapy and recovered from the operative procedure. According to the consensus to treat HP for a purpose to reduce the risk of gastric cancer, these patients were still under risk. There have been only a few surveys on the prevalence of persistent HP infection in patients who have undergone surgery. The aim of the study was to evaluate the prevalence and histological features of HP infection after a time course of partial distal gastric surgery.
Detailed description
The eradication of H pylori is known to reduce the recurrence rate of peptic ulcer and gastric inflammation. But it is still not clear about the prevalence of HP infection in patients after surgical interventions when the micro-environment had been changed. Since biliary enterogastric reflux is suggested to inhibit the growth of HP, we will investigate in a prospective study the effect of partial gastrectomy on the influence of HP infection incidence.
Patients with previous distal gastrectomy will be prospectively evaluated as study group. Same number of patients with the same indication of endoscopy evaluations and without previous gastrectomy will be established as a normal control group for H pylori infection rate comparison. All patients in study and control groups who had previously received H pylori eradication therapy will be excluded. Three gastric biopsy specimens were collected from each patient for histological analysis. Patients with a pre-operative biopsy, operative specimen revealing H pylori colonization or a positive serum H pylori IgG will be indicated previous H pylori infection and will be assessed the percentage of spontaneous clearance of HP infection. A positive bile staining will indicate biliary enterogastric reflux. This assessment will be made by two investigators, and disagreements will be resolved by joint discussion to reach a consensus. Tissue sections stained with hematoxylin and eosin and the Giemsa stain will be examined by pathologist who was unaware of the endoscopy findings. Density of HP in the tissue and histological gastritis activity and intestinal metaplasia will be graded as normal (0), mild (1), moderate (2) and severe (3) based on the Sydney system. Follicular gastritis will be based on the absence (0) or presence (1) of lymphoid follicules and lymphoid with germinal center (2).
The primary end point will be the change of infection rate on HP after distal gastrectomy procedure comparing the normal control. The secondary end point will assess the correlation between the duration of the antrectomy, the operative procedure, the severity of bile reflux with the inhibition of HP growth. Finally, this study will be base on histopathological features with the density of HP, the grading of gastritis activity, intestinal metaplasia and follicular gastritis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with previous distal gastrectomy
Key inclusion criteria (1 listed)
- Previous distal gastrectomy
Key exclusion criteria (1 listed)
- Post HP eradication therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2009.
- Background: PubMed 15362798Fukuhara K, Osugi H, Takada N, Takemura M, Lee S, Taguchi S, Kaneko M, Tanaka Y, Fujiwara Y, Nishizawa S, Kinoshita H. Duodenogastric reflux eradicates Helicobacter pylori after distal gastrectomy. Hepatogastroenterology. 2004 Sep-Oct;51(59):1548-50.
- Background: PubMed 15362799Huang WH, Wang HH, Wu WW, Lai HC, Hsu CH, Cheng KS. Helicobacter pylori infection in patients with ulcer recurrence after partial gastrectomy. Hepatogastroenterology. 2004 Sep-Oct;51(59):1551-3.
- Background: PubMed 17170018Malfertheiner P, Megraud F, O'Morain C, Bazzoli F, El-Omar E, Graham D, Hunt R, Rokkas T, Vakil N, Kuipers EJ. Current concepts in the management of Helicobacter pylori infection: the Maastricht III Consensus Report. Gut. 2007 Jun;56(6):772-81. doi: 10.1136/gut.2006.101634. Epub 2006 Dec 14.
- Background: PubMed 12544692Johannesson KA, Hammar E, Stael von Holstein C. Mucosal changes in the gastric remnant: long-term effects of bile reflux diversion and Helicobacter pylori infection. Eur J Gastroenterol Hepatol. 2003 Jan;15(1):35-40. doi: 10.1097/00042737-200301000-00007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming-Jen Chen, M.D.,M.S. principal investigator
Mackay Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Pylori Infection and Peptic Ulcer, run by Mackay Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wan-Ting Chen (886-2-25433535 ext. 2485, wanting.b352@ms1.mmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00441831, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2009.