Status:
ACTIVE_NOT_RECRUITING
CryoBalloon Ablation for Treatment of Duodenal Adenomas
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Pentax Medical
Conditions:
Duodenal Adenomas
Familial Adenomatous Polyposis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 Med...
Detailed Description
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 ble...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2026
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03847636
Start Date
May 13 2019
End Date
March 1 2026
Last Update
March 11 2025
Active Locations (4)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
2
Northwell Health
Manhasset, New York, United States, 11030
3
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
4
Methodist Dallas Medical Center
Dallas, Texas, United States, 75203