Observation on the Efficacy of Radiofrequency Ablation for Patients With Moderate to Severe Gastric Atrophy With Enterosis With or Without Atrophy of Intraepithelial Neoplasia: An Observational Study

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Atrophic Gastritis
• Intervention / Treatment: Procedure: Radiofrequency ablation alone

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 62

Contacts and Locations

• Study Contact: Name: Xiuli Zuo Zuo; Phone Number: 15665780271; Email: zuoxiuli@sdu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Age 18-70 years old, male or female.
• Patients who had undergone gastroscopy within 3 months prior to inclusion, and whose histologic diagnosis of chronic gastritis was histologically atrophic enterocolitis graded at moderate-to-severe with or without low-grade intraepithelial neoplasia.
• Patients who had undergone gastroscopy within 3 months prior to inclusion, and whose OLGA (atrophic grading and staging criteria for chronic gastritis) or OLGIM (enteric grading and staging criteria for chronic gastritis) staging criteria had reached moderately severe.
• Helicobacter pylori negative.

Exclusion Criteria:

• Pregnant or lactating women.
• Previous history of malignant tumors of the digestive tract or history of gastrointestinal surgery.
• Malignant tumors of other organs, coagulation disorders, cardiopulmonary insufficiency, hepatic and renal insufficiency, etc.
• Those who are unable or unwilling to sign the informed consent form.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	3 Months After Participants Underwent Radiofrequency Ablation

Secondary Outcome Measures

Outcome Measure	Time Frame
Procedure time for radiofrequency ablation therapy in study participants with moderate to severe gastric atrophic enterocolitis with or without low-grade intraepithelial neoplasia	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	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	3 Months After Participants Underwent Radiofrequency Ablation.

Collaborators and Investigators

• Sponsor: Xiuli Zuo

Study record dates

Study Major Dates

• Study Start (Estimated): December 31, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 30, 2028

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 26, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 26, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Gastritis; Gastritis, Atrophic; Atrophy
• Other Study ID Numbers: KYLL-202408-006-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No