An observational study in Atrophic Gastritis, sponsored by Xiuli Zuo. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by Xiuli Zuo · Observational
The aim of this observational study was to understand the effect of radiofrequency ablation on subjects with moderate to severe gastric atrophy with enterocolitis with or without low-grade intraepithelial neoplasia who underwent radiofrequency ablation. The main question it aims to answer is:
Does radiofrequency ablation therapy reduce gastric mucosal atrophy and enterosis in subjects with moderate to severe gastric atrophy with enterosis with or without low-grade intraepithelial neoplasia?
Outpatient or inpatient collection of study participants was done by recruiting participants who met the inclusion criteria and did not meet the exclusion criteria and signed an informed consent form. Study participants were identified for enrollment and a case report form was completed. The basic demographic information of the study participants was recorded, along with the results of existing routine laboratory tests, and symptom-related clinical characteristics. Gastroenterology reports and pathology reports were retained for enrolled study participants to score and grade each study participant specifically, and all study participants were treated with radiofrequency ablation after enrollment. Follow-up gastroscopy was performed on study participants 3 months after treatment, adverse reactions during the two gastroscopies were recorded and case report forms were supplemented, gastroscopy reports and pathology reports of study participants were retained again, and gastroscopy reports and pathology reports of study participants were evaluated, and data on changes were summarized. Follow-up gastroscopy was performed on study participants 3 months after treatment, adverse reactions during the two gastroscopies of study participants were recorded and additional case report forms were completed, gastroscopy reports and pathology reports of study participants were again retained and gastroscopy reports and pathology reports of study participants were evaluated, and data on changes were summarized. Study participants who failed treatment but did not develop new intraepithelial neoplasia summarized the reasons for their failure and were re-treated with radiofrequency ablation 3 months later, and this was repeated until treatment was successful; study participants who developed new low-grade intraepithelial neoplasia were treated with radiofrequency ablation at post-treatment follow-up, and this was repeated until treatment was successful; and study participants who developed new intermediate- and high-grade intraepithelial neoplasia were treated with ESD at post-treatment follow-up, and this was repeated until treatment was successful. All data were summarized at the end of enrollment for all study participants and statistically analyzed.
196 studies on the registry are indexed under Gastritis; 42 are open to participants now.
This study's planned enrollment of 62 is below the median of 400 across 79 observational studies indexed under Gastritis.
Browse Gastritis studies →Xiuli Zuo is the lead sponsor of 10 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study recruited study participants with moderate-to-severe gastric atrophy with enterocolitis with or without low-grade intraepithelial neoplasia detected in the outpatient or inpatient setting; upon entry into the study, study participants were required to meet the inclusion criteria and not to meet the exclusion criteria, and to sign an informed consent form
Exclusion Criteria:
Endoscopic radiofrequency ablation (RFA) consists of delivering a 465 KHz energy waveform to the diseased tissue through an array of bipolar electrodes. The electrodes are mounted externally to the balloon, on an articulating platform attached to the distal end of the endoscope, or on a flexible catheter that penetrates the scope. The principle of radiofrequency ablation is that the action of high-frequency alternating current (HFAC) induces the movement of charged particles within the tissue to generate heat, which results in evaporation of water inside and outside the cell, drying, and solidifying and shedding to the point of aseptic necrosis.RFA has been demonstrated to safely, effectively, and durably eradicate early stage tumors of Barrett's esophagus as well as gastric low-grade endoepithelial neoplasia, and is said by a consensus of experts to be capable of treating moderately severe atrophic enterocolitis that has not yet progressed to gastric low-grade intraepithelial neoplasi
Eradication and remission rates after radiofrequency ablation therapy in study participants with moderate to severe gastric atrophic enterosis with or without low-grade intraepithelial neoplasia
Time frame: 3 Months After Participants Underwent Radiofrequency Ablation
Procedure time for radiofrequency ablation therapy in study participants with moderate to severe gastric atrophic enterocolitis with or without low-grade intraepithelial neoplasia
Time frame: Within 24 hours after the participant underwent radiofrequency ablation
Length of hospitalization for radiofrequency ablation in study participants with moderate to severe gastric atrophic enterocolitis with or without low-grade intraepithelial neoplasia
Time frame: Within 24 hours after participants were successfully discharged from the hospital after undergoing radiofrequency ablation procedures
Incidence of adverse reactions to radiofrequency ablation therapy in study participants with moderate to severe gastric atrophic enterocolitis with or without low-grade intraepithelial neoplasia
Time frame: 3 Months After Participants Underwent Radiofrequency Ablation.
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Plan to share: Undecided
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This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Xiuli Zuo