Preventive Effect of High-Dose Digestive Enzyme Management on Development of Nonalcoholic Fatty Liver Disease after Pancreaticoduodenectomy: A Randomized Controlled Clinical Trial - 23/11/20
, Akira Shimizu, MD, PhD a, Takahide Yokoyama, MD, PhD b, Koji Kubota, MD, PhD a, Tsuyoshi Notake, MD, PhD a, Hitoshi Seki, MD, PhD c, Akira Kobayashi, MD, PhD a, Yuji Soejima, MD, PhD, FACS aAbstract |
Background |
Nonalcoholic fatty liver disease (NAFLD) is a complication of pancreaticoduodenectomy (PD). We conducted a randomized clinical trial to determine if high-dose digestive enzymes prevented the development of NAFLD after PD.
Study Design |
This parallel-group, nonblinded, multicenter study enrolled patients undergoing elective PD at Shinshu University School of Medicine, from June 2011 to April 2017. Patients were randomly assigned to receive normal-dose (Excelase: 3.0 g/day [Meiji Seika Pharma Holdings Co, Ltd]) or high-dose digestive enzyme treatment (Excelase: 3.0 g/day; Pancreatin [Tokyo Chemical Industry Co Ltd]: 3.0 g/day; Berizym [Kyowa Pharmaceutical Industry Co Ltd]: 3.0 g/day; and Toughmac-E [Ono Pharmaceutical Co, Ltd]: 3.0 g/day) within 1 week after surgery. Because patients in the control group switched interventions upon receiving a diagnosis of NAFLD, intention-to-treat analysis was used. The primary endpoint was incidence of NAFLD within 1 year, and the secondary endpoints were the incidences of NAFLD at 1, 3, 6, and 12 months and the rate of improvement in NAFLD with high-dose transfer in the control group. The secondary analysis comprised assessment of risk factors for the development of NAFLD.
Results |
Eighty-four patients were randomly assigned (42 per group), 80 of whom were finally analyzed (39 normal-dose, 41 high-dose). The incidence of NAFLD was significantly lower in the high-dose (8 of 41) compared with the normal-dose (25 of 39) patients (p < 0.001). Multivariate analysis identified normal-dose (odds ratio [OR] 14.65, p < 0.001), total protein ≤ 6.5g/dL (OR 9.01, p = 0.018), pre-albumin ≤ 22.0 mg/dL (OR 7.71, p = 0.018), and pancreatic function diagnostic test ≤ 70% (OR 6.66, p = 0.009) as independent risk factors. There were no adverse effects. The model was accurate (c-index = 0.92) and reliable (Hosmer-Lemeshow test p = 0.32).
Conclusions |
High-dose administration of digestive enzymes significantly reduced the onset of NAFLD after PD compared with normal-dose administration. Registration number: UMIN000005595 (ctr/).
Le texte complet de cet article est disponible en PDF.Abbreviations and Acronyms : BT-PABA, L/S, NAFLD, OR, PD, PF, PFD
Plan
| CME questions for this article available at jacscme.facs.org |
|
| Disclosure Information: Authors have nothing to disclose. Timothy J Eberlein, Editor-in-Chief, has nothing to disclose. Ronald J Weigel, CME Editor, has nothing to disclose. |
|
| Trial Registration: UMIN Clinical Trials Registry (UMIN000005595) |
Vol 231 - N° 6
P. 658-669 - décembre 2020 Retour au numéro
Article précédent
- Reliability of Surgical Risk Calculator Performance Assessment in Single-Institution Data
- Chelsea P. Fischer, Mark E. Cohen, Ryan P. Merkow
- Initial Experience with a Virtual Platform for Advanced Gastrointestinal Minimally Invasive Surgery Fellowship Interviews
- Arnab Majumder, Shaina R. Eckhouse, L Michael Brunt, Michael M. Awad, Francesca M. Dimou, J Christopher Eagon, Sara Holden, Heather Fone, Jeffrey A. Blatnik
Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.
Déjà abonné à cette revue ?