Clinical trial NCT02407119: Effects of H. Pylori Eradication on the Gastric Preneoplastic Lesion and Neoplasm After ESD
Official title: Effect of Helicobacter Pylori Eradication on Glandular Atrophy and Metachronous Cancer in Patients Undergoing Endoscopic Mucosal Resection for Gastric Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Helicobacter Pylori Infection
Early Gastric Cancer
Endoscopic Resection
Keywords: H. pylori eradication
Atrophy
Intestinal metaplasia
Endoscopic resection
Stomach neoplasm
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2015-04-02
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates whether Helicobacter pylori eradication improves precancerous lesions including glandular atrophy and intestinal metaplasia as well as metachronous cancers or dysplasias after endoscopic mucosal resection for gastric cancer.

Detailed description: Helicobacter pylori is a primary etiological agent leading to chronic gastritis and peptic ulcer. The organism is also associated with gastric cancer in epidemiological studies. However detailed mechanism of carcinogenesis remains unknown. Histolopathological studies indicate that chronic H. pylori infection progresses over decades through stages of chronic gastritis, atrophy, intestinal metaplasia, dysplasia and cancer. Gastric atrophy and intestinal metaplasia are considered as precancerous lesions, but whether H. pylori eradication improves these lesions and prevents metachronous gastric cancer is controversial. And the issue has not been evaluated in gastric cancer patients. However, despite the conflicting evidences from two open labelled randomized controlled trials, current guidelines from various regions recommend H. pylori eradication treatment in patients who were treated for gastric cancer by surgically or endoscopically. Thus, it is important to evaluate whether H. pylori eradication can improve known precancerous lesion, i.e. glandular atrophy and intestinal metaplasia in gastric cancer patients. Such histological improvement can eventually reduce secondary gastric cancer development and provide evidence for current guidelines.

Eligibility criteria: Inclusion Criteria:

* Early Gastric cancer or high grade dysplasia confirmed by endoscopy

  * Histologically confirmed well or moderately differentiated adenocarcinoma, or high grade dysplasia
  * Submucosal invasion is not suspected
  * No evidence of ulceration or ulcer scar within the lesion
* Helicobacter pylori infection was confirmed by histological evaluation and rapid urease test
* Pre op CT stage: IA (T1N0M0) according to UICC TNM classification system
* Informed consent should be signed

Exclusion Criteria:

* Recurrent gastric cancer
* Previous serious side effect to antibiotics
* H. pylori eradication treatment history
* Poorly differentiated adenocarcinoma or Signet ring cell carcinoma
* Undergoing operation due to complication of EMR
* Undergoing operation due to remnant cancer
* Other malignancy within the past 5 years
* Pregnant or nursing women
* Serious concurrent infection or nonmalignant disease such as liver cirrhosis, renal failure, cardiovascular diseases
* Psychiatric disorder that would preclude compliance

Primary outcomes:
measure: Improvement (histological) of glandular atrophy
timeFrame: 3 years after enrollment
measure: Incidence of metachronous gastric cancer
timeFrame: 3 years after last patient enrollment
Secondary outcomes:
measure: Incidence of new gastric dysplasia
timeFrame: 3 years after last patient enrollment
measure: Overall survival
timeFrame: 3 years after last patient enrollment
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center, Korea
state: Gyeonggi
Study officials:
affiliation: National Cancer Center, Korea
name: Il Ju Choi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Choi IJ, Kook MC, Kim YI, Cho SJ, Lee JY, Kim CG, Park B, Nam BH. Helicobacter pylori Therapy for the Prevention of Metachronous Gastric Cancer. N Engl J Med. 2018 Mar 22;378(12):1085-1095. doi: 10.1056/NEJMoa1708423.