Neoplasms

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Adenoma

Adenomatous Polyposis Coli

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Polyps

Adenomatous Polyps

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Syndrome

Neoplastic Syndromes, Hereditary

Gastrointestinal Diseases

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Intestinal Diseases

Intestinal Polyposis

Genetic Diseases, Inborn

Familial Adenomatous Polyposis

MYH-associated Polyposis

Individuals with duodenal adenomas (DAs) and FAP with Spigelman class 2,3 or 4, treated with cryoballoon ablation (intervention)

Individuals with at least 1 sporadic duodenal adenoma (DA) between 1-5 cm in maximum diameter, treated with cryoballoon ablation (intervention)

Endoscopic cryoablation (cryogen is contained nitrous) using a CryoBalloon catheter to ablate up to 4 separate DA.

CryoBalloon ablation

Marcia I. Canto, MD

This multicenter prospective non-randomized interventional study (clinical trial) that will assess the safety and efficacy of cryoballoon ablation treatment using the C2 Cryoballoon device (Pentax Medical Corporation) as an alternative primary treatment modality for sporadic and familial nonampullary nonpolypoid (flat) duodenal adenomas.

Duodenal adenomas are precursors to adenocarcinoma. Treatment with endoscopic polypectomy is technically challenging problematic and associated with a high rate of complication - overall 26%, with bleeding 22-40%, higher with larger polyps. Surgery to remove these benign polyps would be a Whipple operation, which has a high morbidity and 1-4% mortality rate. Medical therapies like celecoxib decrease the number of polyps but do not prevent cancer.

This multicenter prospective cohort study will assess the safety and efficacy of cryoablation treatment as an alternative primary treatment modality for sporadic and familial nonampullary nonpolypoid (flat) duodenal adenomas

Prospective studies have demonstrated the safety and efficacy of nitrous oxide focal cryoballoon ablation for complete eradication of Barrett's esophagus (including a clinical trial published by the Principal Investigator), which is intestinal metaplasia, which is histologically similar to normal duodenal mucosa.

When inflated, the cryoballoon flattens the duodenal folds allowing improved visibility of the duodenal lesions. The focal ablation allows precise targeting and avoidance of the ampulla to minimize pancreatitis risk.

Two cases at Johns Hopkins Hospital have been treated successfully and safely using cryogen dose of 10 seconds. The procedures were easy and short, with excellent views of the lesion with balloon inflation and high definition endoscope. No major adverse events, pain requiring treatment, or bleeding were noted. Minor adverse events included transient abdominal bloating lasting for \< 3 days in 1 patient. In one patient with sporadic laterally spreading large Paris 2A polyp who declined standard treatments, complete eradication was achieved with 2 ablation sessions.

In the other patient with familial adenomatous polyposis (FAP) who had 2 hospitalizations for post-polypectomy bleeding after duodenal EMR, complete eradication was noted after 1 treatment of 3 Paris 2A and 2B adjacent polyps.

Follow-up of these two patients shows no recurrence \> 1 year and at the most recent follow-up procedures. Clinical and endoscopic surveillance continues.

In addition, another physician at the University of Texas Health Science Center at San Antonio (UTHSCSA) reported another two patients with duodenal adenomas in her practice treated successfully with cryoballoon ablation without complications. Two other collaborating physicians at Memorial Hermann Texas Medical Center in Houston, Texas, and Geisinger Medical Center in Pennsylvania have also reported favorable response of these challenging neoplasms to endoscopic cryoballoon ablation. The group is currently preparing a case series report and a separate Institutional Review Board application is being submitted.

This study may impact on the management of patients with duodenal adenomas by demonstrating the potential for safe and effective non-operative eradication using cryoballoon ablation. The safety profile of endoscopic cryoballoon ablation is likely to be better than endoscopic resection based on a large clinical and research experience in Barrett's esophagus patients (\>250) and small clinical experience in duodenal adenoma patients, with \<=5% bleeding, no perforation, and transient, mild post-treatment discomfort.

Non-randomized pilot study of highly selected patients

CryoBalloon Ablation for Treatment of Duodenal Adenomas

Safety and Efficacy of Cryoballoon Ablation for Treatment of Sporadic and Familial Nonampullary Nonpolypoid Duodenal Adenomas (the C2D2 Trial)

Submit request to P.I. and study team with study goal.

To assess incidence of treatment-related adverse events following cryoablation using the C2 cryoballoon system, defined by frequency or number of adverse events in all treated patients (per patient analysis).

To assess incidence of treatment-related adverse events following cryoablation using the C2 cryoballoon system, defined by frequency or number of adverse events in all treatment procedures (per procedure analysis).

Complete eradication (CE) rate of DAs as assessed by a combination of endoscopic and pathologic absence of adenomatous tissue in treated areas.

Endoscopic assessment: percent change in adenoma size by blinded review by 3-person expert panel of still images with region of interest marked by tattoo - per lesion analysis and per patient analysis.

Technical failure rate is the proportion of treatment procedures with cryoballoon ablation that did not complete delivery of cryogen to all targeted sites.

Percent change in Spigelman classification for polyp burden in FAP patients from baseline to 1 year after treatment is completed. The Spigelman classification assigns points based upon polyp number, polyp size, histology and dysplasia grade, where Stage 0 = 0 points, Stage I = 1-4 points, Stage II = 5-6 points, Stage III = 7-8 points, and Stage IV = 9-12 points. The higher the score, the more severe or advanced the FAP disease in the duodenum.

Progression rate: percentage of patients with progression of dysplasia grade to high grade dysplasia or invasive cancer, compared to baseline biopsies, at any time during the study.

Time to complete eradication (in months) of all duodenal adenomas in each patient

Time to complete eradication (in months) of each treated DA lesion

Median number of cryoballoon ablation treatments to achieve complete eradication.

Pentax Medical

Johns Hopkins University

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Respiratory Tract Infections

Cold snare endoscopic resection

Non-ampullary sporadic duodenal adenomas (SDA) are rare lesions, incidentally discovered in up to only 5% of patients during routine endoscopy. In any case, these lesions require treatment due to their potential malignant transformation because of the adenoma-carcinoma sequence, occurring in 30-85% of cases. Endoscopic resection (ER) of SDA represents an attractive alternative to surgical resection in appropriately selected patients, with lower morbidity and mortality rates.

However, most endoscopists are not keen to resect larger lesions due to the risk of complications. Indeed, endoscopic resection in the duodenum has unique challenges: thin wall, high vascularity, very limited space and harmful effects of bile and acid both acting on the ER defect.

Cold snare endoscopic resection has been shown to be a viable method for removing colorectal lesions with comparable efficacy outcomes compared to conventional polypectomy/endoscopic mucosal resection (EMR) and a promising safety profile. As a matter of fact, adverse events associated with hot snare resection technique such as delayed bleeding, post-polypectomy syndrome, and perforation are all related to electrocautery-induced injury.

Performing cold snare piece-meal resection and avoiding the need of thermal therapy, may have a major impact in the duodenum where the risk of delayed bleeding and perforation is consistent.

The aim of this pilot study is to prospectively evaluate the feasibility and the efficacy in term of safety and efficacy of cold snare endoscopic resection.

Cold Snare Endoscopic Resection for Duodenal Adenomas

* endoscopic appearance
* scar biopsies
* perforation risk

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CryoBalloon Ablation for Treatment of Duodenal Adenomas	NCT03847636	Duodenal Adenom... Familial Adenom...	CryoBalloon abl...	18 Years -	Johns Hopkins University
Cold Snare Endoscopic Resection for Duodenal Adenomas	NCT04783961	Duodenal Adenom...	Cold snare endo...	18 Years - 99 Years	Istituto Clinico Humanitas
Cold Snare Endoscopic Resection for Duodenal Adenomas	NCT04783961	Duodenal Adenom...	Cold snare endo...	18 Years - 99 Years	Istituto Clinico Humanitas
CryoBalloon Ablation for Treatment of Duodenal Adenomas	NCT03847636	Duodenal Adenom... Familial Adenom...	CryoBalloon abl...	18 Years -	Johns Hopkins University

Spots Global Cancer Trial Database for duodenal adenomas