Does successful EUS-guided pancreatic cyst chemoablation safely allow reduction in the frequency of radiographic surveillance? Long-term follow-up of randomized prospective data.

BACKGROUND AND AIMS: EUS-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 two randomized, prospective, ChARM clinical trials. Additionally, the performance of a post-ablation reduced radiographic surveillance protocol was evaluated using clinical and economic outcomes and patient experience metrics. METHODS: Patients who successfully completed one of the two ChARM randomized control trials were evaluated for durability of response and clinical outcomes. Patients were eligible if two years or more of follow-up were available and complete. We calculated economic outcomes using Medicare allowable costs applicable to EUS, MRI, 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 ACG guidelines over 5 years. Additionally, patients under long-term surveillance in our clinic were interviewed via a 4 question Likert scale questionnaire. RESULTS: 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%) with nonresponse. All patients were successfully reduced to annual or less surveillance without recurrence or the development of cyst associated malignancy. When 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 $7,200.00 versus $19,437.44 and $12,526.52 if untreated and followed under Fukukoa or ACG guidelines, respectively. The patient experience questionnaire was returned completed by 49 participants. CONCLUSIONS: The 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 was shown when compared to management following Fukukoa or ACG guidelines. According to the questionnaire, most patients reported a moderate level of logistical and emotional burden associated with MRI surveillance, and a majority were in favor of reducing the frequency of radiographic surveillance if it can be done without a marked increase in oncologic risk.