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

NCT06751212 | Not Yet Recruiting

• 1 other identifier: KYLL-202408-006-1
• Study Type: observational
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief Summary

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?

Conditions

Atrophic Gastritis

Outcome Measures

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

  3 Months After Participants Underwent Radiofrequency Ablation

Secondary Outcomes (3)

• 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.

Interventions

Radiofrequency ablation alone PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Age 18-70 years old, male or female.
• Helicobacter pylori negative.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiuli Zuo: lead

MeSH Terms

Conditions

Gastritis, Atrophic

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Gastritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Xiuli Zuo Zuo

CONTACT

15665780271; zuoxiuli@sdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 27, 2024
• Study Start: December 31, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 30, 2028
• Last Updated: December 27, 2024

Record last verified: 2024-12