THE EFFECTS OF HIGH DOSE PANCREATIC ENZYME REPLACEMENT THERAPY ON BODY WEIGHT, NUTRITIONAL ASSESSMENT AND QUALITY OF LIFE AFTER PANCREATICODUODENECTOMY
Hongbeom Kim*, Wooil Kwon, Mirang Lee, Sun-Whe Kim, Jin-Young Jang
Surgery, Seoul National University Hospital, Gyeonggi-do, Goyang-si, Korea (the Republic of)
Background
Many patients with pancreatectomy are facing discomforts from malnutrition or deteriorating quality of life (QOL). Pancreatic exocrine insufficiency (PEI) can occur after pancreatectomy, leading to nutritional imbalance and weight loss. In addition to nutritional deficits, there are also changes in the QOL, such as steatorrhea, changes in bowel habit or flatulence. Pancreatic enzyme replacement therapy (PERT) are helpful for PEI patients. However, there was no consensus of PERT for EPI patients after pancreatectomy. Therefore, we aimed to find out the effect of PERT on body weight, bowel habit, nutritional status and QOL, in patients with PEI after pancreaticoduodenectomy.
Methods
This randomized controlled, placebo-using, double-blind and multicenter trial compared effect of PERT to placebo. Patients were enrolled in 7 tertiary referral hospitals. Among the patients who underwent pancreaticoduodenectomy regardless of benign or malignant diseases, the patients who were a fecal elastase level was 200 or less in preoperative or postoperative test were included in this study. The PERT group took single capsule of pancreatin 40000 IU three times a day while taking a meal for 3 months. Protocol completion defined as taking more than two thirds of total dose and without taking other digestive enzyme. The primary endpoint was change of body weight. The secondary endpoint was change of bowel habit, nutritional parameters and QOL.
Results
Between October 2014, and September 2017, 304 patients were randomly assigned. The protocol-completed patients were 71 and 93, in PERT group and in control group, respectively. In per-protocol set, 1.09kg weight increased in PERT group for 3 months, on the other hands, 2.28kg weight reduction in placebo group. There was significant weight difference of 3.37kg (p < 0.001). However there was no difference in intention-to-treat set. (figure1) Of the change of nutritional parameters, prealbumin showed significant difference (PERT: +10.9 mg/dL vs placebo: +7.8 mg/dL, p=0.002). And transferrin also show difference between PERT group and placebo group, however there was no statistical significance (+84 mg/dL in PERT vs +76.1 mg/dL placebo, p=0.063). Pre-operative high BMI and poor compliance of PERT were weight loss risk factors in univariate analysis. However most powerful weight loss risk factors was poor PERT compliance (HR: 4.018, p value < 0.001). There was no PERT effect in sub-category QOL scores as well as total score.
Conclusion
PERT as a nutritional support increase weight and nutritional parameters in post-operative PEI patients. Active education and monitoring are important to maximize effectiveness.
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