Table 3. Summary of studies for EUS-guided ethanol ablation with or without paclitaxel and gemcitabine.
| Author, year | Study Type | Conditions (no. patients) | Complete (CR) or partial resolution (PR) | Clinically significant AEs 1 |
| Studies that used ETOH for ablation | ||||
| Gan et al. 2005 14 | Prospective (pilot) |
5 – 80 % ETOH (25) | 35 % CR 7 % PR |
0 % |
| Dewitt et al. 2009 10 | Prospective (RCT) | 80 % ETOH (25) SALINE (17) |
33 % CR
2
0 % CR |
24 % (4 % pancreatitis, 20 % abdominal pain) 12 % (abdominal pain) |
| Dimaio et al. 2011 17 | Retrospective | 80 % ETOH (13) | 38 % CR | 8 % (abdominal pain) |
| Gomez et al. 2016 50 | Prospective (pilot) | 80 % ETOH (23) | 9 % CR 44 % PR |
8 % (4 % pancreatitis, 4 % abdominal pain) |
| Studies that used ETOH and paclitaxel for ablation | ||||
| Oh et al. 2008 15 | Prospective | 88 – 99 % ETOH + paclitaxel (14) | 79 % CR 14 % PR |
21 % (7 % pancreatitis, 14 % abdominal pain) |
| Oh et al. 2009 16 | Prospective | 99 % ETOH + paclitaxel (10) | 60 % CR 20 % PR |
10 % (abdominal pain) |
| Oh et al. 2011 9 | Prospective | 99 % ETOH + paclitaxel (47) | 62 % CR 13 % PR |
4 % (2 % pancreatitis, 2 % abdominal pain) |
| Dewitt et al. 2014 11 | Prospective | 100 % ETOH + paclitaxel (22) | 50 % CR 25 % PR |
23 % (10 % pancreatitis, 13 % abdominal pain) |
| Studies that used ETOH, paclitaxel and gemcitabine for ablation | ||||
| Moyer et al. 2016 12 | Prospective (pilot) | 80 % ETOH then paclitaxel + gemcitabine (4) Saline then paclitaxel + gemcitabine (6) |
75 % CR 67 % CR |
20 % (pancreatitis) 0 % |
| Moyer et al. 2017 8 | Prospective RCT | 80 % ETOH then paclitaxel + gemcitabine (18) Saline then paclitaxel + gemcitabine (21) |
61 % CR 67 % CR |
Serious AE 6 %, minor AE 22 % Serious AE 0 %, minor AE 0 % |
ETOH, ethanol alcohol; CR, complete response; PR, partial response; AE, adverse event; RCT, randomized clinical trial.
The overall % of AEs described here represents the sum of AEs reported in corresponding studies (in parentheses), focusing on the two most common AEs reported: abdominal pain and pancreatitis. However, based on reported study results, it cannot be determined whether AE categories overlapped (e. g., whether a patient documented with pancreatitis also counted toward the reported AE rate for abdominal pain). Other less commonly reported AEs include intracystic bleeding (26), splenic vein obliteration (21), hyperamylasemia (20), gastric wall cyst (27), and peritonitis (27)
In this study, 23 % of patients undergoing saline lavage and a second ETOH lavage had CR, 33 % undergoing ETOH lavage twice had CR, and 75 % undergoing a single ETOH lavage had CR[ 3] The published results [12] are from a smaller sample (N = 10; ETOH arm: 75 % CR, 20 % AEs; ETOH-free arm: 67 % CR, 0 % AEs), but the final randomized controledl trial is listed at the bottom (8).