Clinical Trials Logo

Clinical 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 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT00441831
Study type Observational
Source Mackay Memorial Hospital
Contact Wan-Ting Chen
Phone 886-2-25433535
Email wanting.b352@ms1.mmh.org.tw
Status Recruiting
Phase N/A
Start date February 2007
Completion date February 2008

See also
  Status Clinical Trial Phase
Recruiting NCT05061732 - Helicobacter Pylori Eradication and Follow-up Phase 4
Completed NCT03779074 - Comparing the Efficacy of Hybrid, High-dose Dual and Bismuth Quadruple Therapies Phase 3
Completed NCT06076681 - A Study to Evaluate Preliminary Helicobacter Pylori Eradication After Multiple Doses of TNP-2198 Capsules Combined With Rabeprazole Sodium Enteric-coated Tablets, or Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules Phase 1/Phase 2
Recruiting NCT05329636 - Auto Fecal Microbial Transplant Post Helicobacter Pylori Antibiotic Therapy Phase 1/Phase 2
Recruiting NCT05065138 - Comparison of Helicobacter Pylori Eradication Effect Before and After Training of Gastroenterologists N/A
Completed NCT05049902 - Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication Phase 4
Not yet recruiting NCT06200779 - Tailored vs. Empirical Helicobacter Pylori Infection Treatment Phase 4
Not yet recruiting NCT06037122 - Efficacy of Low-dose Vonoprazan for Helicobacter Pylori Eradication
Completed NCT04617613 - Comparing Different Regimens for Eradication of Helicobacter Pylori in Kuwait Phase 4
Completed NCT02557932 - Comparison of 7-day PPI-based Standard Triple Therapy and 10-day Bismuth Quadruple Therapy for H. Pylori Eradication Phase 3
Completed NCT02873247 - Standardize Communication With General Practitioner & Patient for Improved Eradication of Helicobacter Pylori
Withdrawn NCT02552641 - Food Effect on the Eradication Rate of H. Pylori With Triple Therapy With Esomeprazole Phase 4
Recruiting NCT02249546 - Efficacy of Acetylcysteine-containing Triple Therapy in the First Line of Helicobacter Pylori Infection Phase 4
Completed NCT01933659 - Anti-H. Pylori Effect of Deep See Water Phase 3
Unknown status NCT01464060 - 14-day Quadruple Hybrid vs. Concomitant Therapies for Helicobacter Pylori Eradication Phase 4
Completed NCT00841490 - Oral H. Pylori Prevalence in Intellectually & Developmentally Disabled Adults N/A
Recruiting NCT05549115 - Susceptibility-Guided Sequential Therapy for Helicobacter Pylori Infection N/A
Recruiting NCT05728424 - One vs Two Weeks Treatment for H.Pylori Eradication A RANDOMIZED NON-INFERIORITY PLACEBO CONTROLLED TRIAL Phase 3
Recruiting NCT05997433 - Efficacy of 7-day Versus 14-day Bismuth Quadruple Therapy for the Eradication of Helicobacter Pylori(SHARE2302) N/A
Completed NCT04708405 - The Relationship Between Helicobacter Pylori Infection and Inflammatory Bowel Diseases: A Real-life Observation