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.

The Safety and Efficacy of an Alcohol-Free Pancreatic Cyst Ablation Protocol

“…Furthermore, the efficacy of alcohol when used alone is weak, and its role in the ablative process is unknown and controversial. 9,10,27,28 In this paper, we report the results of a prospective, randomized, double-blind, clinical trial comparing a completely alcohol-free chemoablation approach with conventional alcohol lavage with both arms then treated with a chemotherapeutic cocktail tailored specifically to pancreatic neoplasia (gemcitabine þ paclitaxel). The results reveal 2 important discoveries.…”

Endoscopic Ultrasound-Guided Ablation of Focal Pancreatic Lesions: The GRUPUGE Perspective

“…In the most recent trials, the ablation solution includes paclitaxel at a 3 mg/mL concentration, which is injected and left inside the cyst [8, 13, 15]. Two recent RCTs showed that ethanol may increase the rate of complications and is not required for effective cyst ablation when a multiagent ablation solution of paclitaxel (3 mg/mL) + gemcitabine (19 mg/mL) is used [6, 15].…”

Endoscopy-guided ablation of pancreatic lesions: Technical possibilities and clinical outlook

“…Since complete ablation rates of 60%-79% have been reached in studies that added paclitaxel to ethanol, Moyer et al[ 78 ] recently published a prospective randomized trial pilot study (CHARM). The authors compared the efficacy of either an ablation with saline plus a chemotherapy cocktail of gemcitabine and paclitaxel or of an alcohol-free regimen with saline and the same chemotherapeutic agents in 10 patients with PLCs.…”