## Protocol Section
### Identification Module
**NCT ID:** NCT05645679

**Acronym:** HYBRID

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

**Official Title:** Efficacy and Safety of HYbrid Argon Plasma Coagulation Technique in Patients With Barrett's Esophagus-Related Dysplasia: a Multicenter Italian Prospective stuDy

#### Organization Study ID Info
**ID:** 2858
#### Organization
**Class:** OTHER
**Full Name:** Istituto Clinico Humanitas
### Status Module
#### Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-12-09

**Type:** ACTUAL

**Last Update Submit Date:** 2022-12-01

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-04-02

**Type:** ACTUAL

**Status Verified Date:** 2022-12

#### Study First Post Date
**Date:** 2022-12-09
**Type:** ACTUAL
**Study First Submit Date:** 2022-12-01
**Study First Submit QC Date:** 2022-12-01
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Istituto Clinico Humanitas

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Barrett's Esophagus

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** Hybrid Argon Plasma Coagulation System

**Name:** Hybrid Argon Plasma Coagulation System

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** percentage of patients with complete eradication of all Barrett's epithelium on endoscopy and CE-IM in all biopsies obtained at the first follow-up endoscopy after the maximum of 5 treatment sessions (and escape treatment(s) if necessary).

the percentage of patients with CE-D in all biopsies obtained at the first follow-up endoscopy after the maximum of 5 treatment sessions (and escape treatment(s) if necessary).

**Measure:** Efficacy of the Hybrid Argon Plasma Coagulation Technique

**Time Frame:** 2 years

### Eligibility Module

**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 Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** 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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** alessandro.repici@humanitas.it

**Name:** Alessandro Repici, MD

**Phone:** 0039-02-82247493

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Milano

**Contacts:**

***Contact 1:***

- **Email:** alessandro.repici@hunimed.eu

- **Name:** Alessandro Repici, MD

- **Phone:** 0039-02-82244507

- **Role:** CONTACT

**Country:** Italy

**Facility:** Humanitas Research Hospital

**Status:** RECRUITING

**Zip:** 20089

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011230

- Term: Precancerous Conditions

- ID: D000009369

- Term: Neoplasms

- ID: D000004935

- Term: Esophageal Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000004066

- Term: Digestive System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4765

- Name: Barrett Esophagus

- Relevance: HIGH

- As Found: Barrett's Esophagus

- ID: M14111

- Name: Precancerous Conditions

- Relevance: LOW

- As Found: Unknown

- ID: M8085

- Name: Esophageal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001471

- Term: Barrett Esophagus

### Misc Info Module

- Version Holder: 2024-05-24
