Berberine for the intestinal metaplasia after endoscopic therapy for early-stage gastric cancer

JRCT ID: jRCTs031210319

Registered date:16/09/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with gastric intestinal metaplasia after endoscopic therapy for early-stage gastric cancer
• Date of first enrollment: 20/06/2022
• Target sample size: 30
• Study type: Interventional

Intervention(s)

After the study registry, intestinal metaplasia score of gastric corpus upper gastrointestinal endoscopy and gastric biopsy (updated Sydney system) is evaluated, and only cases with 2 or more score continue to the intervention of (1) or (2) by randomized method. The ratio of (1) and (2) is 2:1 with minimization method. In the cases with 1 or less score, the case finish the study.
(1) Berberine group
patients take berberine 100mg three times a day (300mg per day) for 180 days
(2) No medication follow up group
patients don't take berberine for 180 days

Outcome(s)

Primary Outcome

Improvement rate of histological intestinal metaplasia in gastric corpus
Definition: In this study, patients with two or more score of intestinal metaplasia score (updated sydney system) in gastric corpus are intervened. After the intervention with berberine group or control group, patients with one or less the score defined as improved. Primary outcome is improvement rate.

Secondary Outcome

1) Change between before and after intervention: histological intestinal metaplasia score of gastric corpus (updated Sydney system)
2) Change between before and after intervention: histological intestinal metaplasia score of gastric antrum (updated Sydney system)
3) Change between before and after intervention: histological intestinal metaplasia score of gastric angle (updated Sydney system)
4) Change between before and after intervention: histological chronic inflammation score of gastric corpus (updated Sydney system)
5) Change between before and after intervention: histological chronic inflammation score of gastric antrum (updated Sydney system)
6) Change between before and after intervention: histological chronic inflammation score of gastric angle (updated Sydney system)
7) Change between before and after intervention: histological acute inflammation score of gastric corpus (updated Sydney system)
8) Change between before and after intervention: histological acute inflammation score of gastric antrum (updated Sydney system)
9) Change between before and after intervention: histological acute inflammation score of gastric angle (updated Sydney system)
10) Change between before and after intervention: histological atrophy score of gastric corpus (updated Sydney system)
11) Change between before and after intervention: histological atrophy score of gastric antrum (updated Sydney system)
12) Change between before and after intervention: histological atrophy score of gastric angle (updated Sydney system)
13) Change between before and after intervention: Total endoscopic gastric cancer risk score (Kyoto classification of gastritis): total of atrophy, intestinal metaplasia, diffuse redness, enlarged fold, and nodular.
14) Change between before and after intervention: endoscopic atrophy score (Kyoto classification of gastritis)
15) Change between before and after intervention: endoscopic intestinal metaplasia score (Kyoto classification of gastritis)
16) Change between before and after intervention: endoscopic diffuse redness score (Kyoto classification of gastritis)
17) Change between before and after intervention: endoscopic enlarged fold score (Kyoto classification of gastritis)
18) Change between before and after intervention: endoscopic nodular score (Kyoto classification of gastritis)
19) Change between before and after intervention: immunostaining of intestinal metaplasia marker CDX2
20) Change between before and after intervention: immunostaining of intestinal metaplasia associated marker ISX

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1)Person who have endoscopic therapy history for early-gastric cancer and whose early-gastric cancer was pathologically curative resected. Gastric cancer histological type is note limited.
(2)Person whose background gastric mucosa at the point of endoscopic therapy for early-gastric cancer was diagnosed as histological intestinal metaplasia
(3)Person who is 20 years or older
(4)Both sexes
(5)Person who can declare agreement for registering by understanding the study and signing the document after hearing the explanation

Exclude criteria

(1)Person who take berberine as medication within a year
(2)Person who take berberine as supplement within a year
(3)Hemorrhagic colitis patient
(4)Bacterial enteritis patient
(5)Patient who successfully eradicated Helicobacter pylori within a year
(6)Patient regularly taking COX2 inhibitor
(7)Patient regularly taking NSAIDs
(8)Patient regularly taking anticoagulants (warfarin, edoxaban, dabigatran, rivaroxaban, apixaban)
(9)Patient regularly taking antiplatelet drug (aspirin, ticlopidine, clopidogrel, cilostazol, Ethyl icosapentate, clopidogrel)
(10)Pregnant
(11)Patients who are disqualified for the study by physicians

Related Information

• Primary Sponsor: Sue Soichiro