CryoBalloon Ablation for Treatment of Duodenal Adenomas

Completed · Not applicable

Conditions studied: Duodenal Adenomas, Familial Adenomatous Polyposis

In brief

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.

Key facts

Study ID

NCT03847636

Run by

Johns Hopkins University

People needed

33

Starts

2019-05-13

Expected to finish

2026-06-01

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Sporadic duodenal adenomas between 1 to 5 cm in widest diameter
• FAP patient with Spigelman class 2, 3 or 4 (see definition below)
• Polyp characteristics: Non-polypoid lesions Paris 2A and 2B, or
• Sessile adenomas, occupying no more than 50% circumference of duodenum, and no more than 3 duodenal folds
• Individuals must be considered high risk for surgery or endoscopic resection, due to complication risk, or declined standard therapies.
• Prior endoscopic mucosal resection (EMR) or saline-assisted polypectomy allowed if polyp characteristics meet inclusion criteria.

You may not qualify if…

• Suspected or proven duodenal carcinoma
• Paris 1p pedunculated, Paris 2c, or 3 lesions
• Paris 1s lesion > 4 mm thick (estimated with closed biopsy forceps)
• Ampullary lesion or lesion involving the ampulla
• Prior failed ablative treatment with Argon Plasma Coagulation, laser, or cryotherapy
• Pre-existing esophageal, gastric, pyloric, or duodenal stenosis/stricture preventing advancement of a therapeutic endoscope during screening/baseline esophagogastroduodenoscopy (EGD.) Subjects are eligible if the stenosis/stricture is dilated to at least 15mm, but baseline treatment may need to be delayed.
• Any endoscopically-visualized abnormalities such as ulcers, masses or nodules during screening/baseline EGD within 3 cm of the treatment area.
• Subjects with nodular polyps or suspicion of invasive cancer by white light endoscopy /enhanced imaging/biopsy identified during screening/baseline EGD
• Suspicion of malignancy by abdominal or endoscopic ultrasound imaging based on malignant lymph nodes, invasion of lesion beyond mucosa.
• EMR or polypectomy < 6 weeks prior to baseline treatment.
• Untreated invasive esophageal malignancy, including margin-positive EMR.
• Active duodenitis in treatment zone during screening/baseline EGD.
• Severe medical comorbidities precluding endoscopy, or limiting life expectancy to less than 2 years in the judgment of the endoscopist.
• Uncontrolled coagulopathy or inability to be off anticoagulation or anti-platelet medication per standards of the institutions performing cryoablation.
• Known portal hypertension, visible esophageal, gastric, or duodenal varices, or history of varices.
• General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation.
• Pregnant or planning to become pregnant during period of study participation.
• Patient refuses or is unable to provide written informed consent.

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Northwell Health — Manhasset, New York, United States
• Geisinger Medical Center — Danville, Pennsylvania, United States
• Methodist Dallas Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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