Is alcohol required for effective pancreatic cyst ablation? The prospective randomized CHARM trial pilot study

Abstract

Background and study aims: In this study, we aim to determine the safety and feasibility of an alcohol-free approach to pancreatic cyst ablation using a chemotherapeutic ablation cocktail.

Patients and methods: In this prospective, randomized, double-blinded pilot study, 10 patients with known mucinous type pancreatic cysts underwent endoscopic ultrasound (EUS)-guided fine needle aspiration and then lavage with either 80 % ethanol or normal saline. Both groups were then treated with a cocktail of paclitaxel and gemcitabine. Primary outcomes were reduction in cyst volume and rates of complications.

Results: At 6 months, patients randomized to the alcohol arm had an 89 % average volume reduction, with a 91 % reduction noted in the alcohol-free arm. Complete ablation was achieved in 67 % of patients in the alcohol-free arm at both 6 and 12 months, whereas the alcohol group recorded complete ablation rates of 50 % and 75 % at 6 and 12 months, respectively. One patient in the alcohol arm developed acute pancreatitis (20 %) with no adverse events in the alcohol-free arm.

Conclusions: This study revealed similar ablation rates between the alcohol ablation group and the alcohol-free arm and demonstrates the safety and feasibility of an alcohol-free ablation protocol. This pilot study suggests that alcohol may not be required for effective cyst ablation.

Fig. 1

In use compatibility and stability testing of gemcitabine/paclitaxel, as measured by HPLC analysis. Gemcitabine (Gemzar, Eli Lilly, 38 mg/mL) and paclitaxel (Hospira, 6 mg/mL) were mixed 1:1 in a syringe and stored at room temperature for 24 hours. Analyte peak area was measured to indicate the amount of gemcitabine (a) and paclitaxel (b) in the original formulations compared to the 1:1 mixture.

Fig. 2 a

MRI image showing a 76-year-old female with a 4.2-cm mucinous (premalignant) type pancreatic cyst (white arrow) prior to EUS-guided chemoablation. b CT image showing a 4-mm residual defect at 1 year (black arrow).

Fig. 3

Volume of cysts post-treatment