Successful EUS-guided pancreatic cyst chemoablation safely allows reduction in the frequency of radiographic surveillance: long-term follow-up of randomized prospective data.

BACKGROUND AND

aimsEndoscopic ultrasound-guided pancreatic cyst chemoablation is safe and effective for appropriately selected patients; however, the proper frequency of radiographic surveillance after successful chemoablation is unknown. Here we report the long-term follow-up of 2 randomized prospective Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts (ChARM) clinical trials. In addition, the performance of a postablation-reduced radiographic surveillance protocol was evaluated according to clinical and economic outcomes and patient experience metrics.

methodsPatients who successfully completed 1 of the 2 ChARM randomized control trials were evaluated for durability of response and clinical outcomes. Patients were eligible if 2 years or more of follow-up were available and complete. We calculated economic outcomes according to Medicare allowable costs applicable to endoscopic ultrasound, magnetic resonance imaging, and outpatient clinic visits. We modeled costs of a patient followed by the ChARM Post-treatment Reduced Radiographic Surveillance Protocol compared with a similar patient followed under Fukuoka or American College of Gastroenterology (ACG) guidelines over 5 years. In addition, patients under long-term surveillance in our clinic were interviewed via a 4-question Likert-type questionnaire.

resultsA total of 52 patients were eligible and included in the study. At the most recent follow-up of the 52 patients, 36 (69.2%) achieved complete response, an additional 11 (21.2%) showed partial response, and only 5 (9.6%) showed nonresponse. All patients were successfully reduced to annual or less surveillance without recurrence or the development of cyst-associated malignancy. Compared with Fukukoa or ACG guidelines, a patient treated and followed under the ChARM Post-treatment Reduced Radiographic Surveillance Protocol incurred a Medicare allowable cost of $7200.00 versus $19,437.44 and $12,526.52 if untreated and observed under Fukukoa and ACG guidelines, respectively. The patient experience questionnaire was returned completed by 49 participants.

conclusionsThe ChARM Post-treatment Reduced Radiographic Surveillance Protocol safely allows a reduction in radiographic surveillance. A reduction in cost associated with cyst management under the ChARM protocol, compared with management following Fukukoa or ACG guidelines, was shown. According to the questionnaire, most patients reported a moderate level of logistical and emotional burden associated with magnetic resonance imaging surveillance, and a majority were in favor of reducing the frequency of radiographic surveillance if it could be done without a marked increase in oncologic risk.