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Clinical Trial
, 21 (3), 542-551

Pancreatic Enzyme Supplementation After Gastrectomy for Gastric Cancer: A Randomized Controlled Trial

Affiliations
Clinical Trial

Pancreatic Enzyme Supplementation After Gastrectomy for Gastric Cancer: A Randomized Controlled Trial

Marco Catarci et al. Gastric Cancer.

Abstract

Background: Gastrectomy for gastric cancer is a significant cause of secondary exocrine pancreatic insufficiency. Pancreatic enzyme replacement therapy may influence nutritional status and quality of life after gastrectomy, but the pertinent clinical research to date remains controversial. A randomized controlled trial to test this hypothesis was carried out.

Methods: After gastrectomy, 43 patients with gastric cancer were randomly assigned to a normal diet (Normal-d; n = 21) or to a pancreatic enzyme supplementation diet (PES-d; n = 22) and were followed up during a 12-month period, assessing nutritional status and quality of life through body mass index (BMI), instant nutritional assessment (INA) class status, serum pre-albumin (SPA) values, and GastroiIntestinal Quality of Life Index (GIQLI).

Results: BMI was not significantly influenced by the type of diet; INA class status was significantly improved in the PES-d arm, particularly during the first 3 months after gastrectomy; SPA levels increased in both arms at 6 months after gastrectomy, reaching significantly higher values in the PES-d arm at 12 months. GIQLI was not significantly influenced by the type of diet throughout the follow-up period; however, this index significantly improved in the PES-d arm between the first and third month after gastrectomy.

Conclusions: PES-d improves nutritional status and quality of life after gastrectomy for gastric cancer, particularly within 3 months from the operation. A larger, multicenter trial is necessary to address the potential influence of several confounding variables such as disease stage and adjuvant treatments.

Keywords: Exocrine pancreatic insufficiency; Gastrectomy; Stomach neoplasms.

Conflict of interest statement

Ethical standards

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation and with the Helsinki Declaration of 1964 and later versions. Informed consent or substitute for it was obtained from all patients for being included in the study.

Conflict of interest

The authors declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1
Enrollment flowchart. PES pancreatic enzyme supplementation
Fig. 2
Fig. 2
Time trend analysis of body mass index (BMI) according to randomization arm (a) and randomization arm and type of surgery (b). PES pancreatic enzyme supplementation, TG total gastrectomy, DSG distal subtotal gastrectomy, d diet
Fig. 3
Fig. 3
Time trend analysis of INA class status according to the randomization arm: normal diet (a); PES diet (b)
Fig. 4
Fig. 4
Time trend analysis of serum pre-albumin according to randomization arm (a) and randomization arm and type of surgery (b). PES pancreatic enzyme supplementation, TG total gastrectomy, DSG distal subtotal gastrectomy, d diet
Fig. 5
Fig. 5
Time trend analysis of GIQLI score according to randomization arm (a) and randomization arm and type of surgery (b). PES pancreatic enzyme supplementation, TG total gastrectomy, DSG distal subtotal gastrectomy, d diet

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