Efficacy and Safety of HYbrid Argon Plasma Coagulation Technique in Patients With Barrett's Esophagus-Related Dysplasia

NCT ID: NCT05645679

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-02
• Study Completion Date: 2024-12-31

Brief Summary

Background Barrett's esophagus (BE) is defined by AGA as "a change in the esophageal epithelium of any length that can be recognized at upper endoscopy and is confirmed to have intestinal metaplasia by biopsy". It is a pre-malignant condition and may progress to low grade dysplasia, high grade dysplasia and ultimately esophageal adenocarcinoma which has poor prognosis with a 5-year survival rate of only 5-20%.Radiofrequency ablation (RFA) is a standard modality and well-studied endoscopic treatment for dysplastic BE. While the rate of complete eradication of dysplasia has been reported to be between 78% - 94% with RFA, the rate of complications associated with this procedure has been reported to be as high as 19.1%, and the costs are high. In a randomized clinical trial in patients with BE and low-grade dysplasia by Phoa et al in 2014, 68 patients underwent radiofrequency ablation therapy with a median of three ablation sessions per patient while 68 patients were randomized to endoscopic surveillance. In this study, a total of 13 patients (19.1%) experienced an adverse event in the treatment group versus no adverse events in the control group. Eight patients (11.8%) developed esophageal strictures which required a median of one dilation, three patients were noted to have small mucosal lacerations, one patient developed retrosternal pain treated with analgesics while one patient developed abdominal pain requiring hospitalization and treatment with analgesia. Several other studies have reported the rate of complications ranging between 5% to 19.1% and stricture formation being the most common among them. Hybrid argon plasma coagulation (H-APC) is a newer technique that involves submucosal fluid injection prior to performing APC. The injection of solutions (e.g., 0.9% sodium chloride solution (normal sterile saline) with or without supplementation of epinephrine, methylcellulose solution, hydroxyethyl starch, hyaluronic acid, autologous blood or blood substitute fluids) into the submucosa to limit the depth of thermal injury has been established both in pre-clinical studies for different tissues of the gastrointestinal tract and in the clinical practice for EMR and ESD, respectively.

Conditions

Barrett's Esophagus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Hybrid Argon Plasma Coagulation System

Hybrid Argon Plasma Coagulation System

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients with histopathologically confirmed LGD or HGD, or residual BE (Prague Classification ≤C3 / ≤M5) after endoscopic resection of a focal lesion containing LGD, HGD or early (≤T1sm1) cancer in the participating centres are eligible for study participation.

Exclusion Criteria

• Younger than 18 years of age at time of consent
• Esophageal stenosis preventing advancement of a therapeutic endoscope
• Prior distal oesophagectomy
• Previous ablation therapy of the esophagus
• Active oesophagitis grade B or higher (patients can be included after appropriate treatment of reflux oesophagitis)
• History of oesophageal varices
• Achalasia
• Severe medical comorbidities precluding endoscopy
• Uncontrolled coagulopathy
• Pregnant or planning to become pregnant during period of study participation
• Life expectancy ≤2 years, as judged by the site investigator

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Humanitas Research Hospital

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Alessandro Repici, MD

Role: CONTACT

alessandro.repici@humanitas.it

0039-02-82247493

Facility Contacts

Alessandro Repici, MD

Role: primary

alessandro.repici@hunimed.eu

0039-02-82244507

References

Massimi D, Maselli R, Pecere S, Spada C, Andrisani G, Di Matteo FM, La Terra A, Coppola F, Capogreco A, De Sire R, Alfarone L, Menini M, Spadaccini M, Hassan C, Repici A. Efficacy and safety of H-APC in Barrett's esophagus: Italian prospective multicenter study. Endosc Int Open. 2025 Feb 26;13:a25318227. doi: 10.1055/a-2531-8227. eCollection 2025.

Reference Type: DERIVED

PMID: 40018075 (View on PubMed)

Other Identifiers

2858

Identifier Type: -

Identifier Source: org_study_id