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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorXiuli Zuo

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Radiofrequency ablation alone

    Procedure/Surgery

    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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xiuli Zuo

Lead sponsor

Shandong University

Sponsor institution

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