The effect of pancreatic enzyme replacement therapy on mucosal visibility during upper gastrointestinal endoscopy: a prospective, randomized, double blind study

Aims Mucosal visibility during upper gastrointestinal endoscopy may be suboptimal due ingested saliva bubles formation and the presence of mucus. Current effective strategies to improve it include administration of simethicone, N-acetyl cysteine and/or pronase, in different combinations and dosages, 10 to 30 minutes before procedure. We aimed to assess the effect of pancreatic enzyme replacement therapy (PERT) administered before examination, on gastric mucosal visibility.

Methods We designed a monocentric, double blind, randomized trial designed to assess the effect of intake of KREON 25000 UI capsules before upper gastrointestinal endoscopy on gastric mucosal visibility. Two groups were compared. In the first group, opened KREON 25000 UI microspheres capsules were dissolved in 50ml sodium bicarbonate solution and ingested 30 minutes before procedure, while in the second group, only 50ml sodium bicarbonate solution was ingested. Mucosal visibility was assessed by the endoscopist using the Crema Stomach Cleaning Score (CSCS) [1]. Patient and endoscopist experience were assessed on a 10 points visual scale.

Results 42 patients (22 women, mean age 56+/- 14 years), were included and randomized in 2 equal groups – PERT plus bicarbonate solution group (PERT) and bicarbonate solution alone group (B). The groups were comparable in terms of sex ratio (p=0.354), age distribution (p=0.399), history of previous upper gastrointestinal endoscopy (p=0.756), anxiety score (p=0.170) and use of deep sedation (p=1.00). The mean duration of the procedure was 297+/- 115 seconds, without significant difference among groups (p=0.660). There was no significant difference in patient discomfort score (p=0.605), pain score (p=0.686), satisfaction score (p=0.925) and gag reflex score (p=1.00), and there was no difference as well in the endoscopist score (p=0.114). There were no differences in mucosal visibility CSCS among groups (KREON group median 7, range [5 – 9] and bicarbonate only group median 7, range [3 – 9], p=0.681). When comparing separate scores for antrum, body and fundus, there were no significant differences among the two study groups (antrum p=0.531, body p=0.877, fundus p=0.407).

Conclusions PERT intake before upper gastrointestinal endoscopy does not seem to improve gastric mucosal visibility.

Publication History

Article published online:
27 March 2025

• References

• 1 Manfredi G, Bertè R, Iiritano E, Alicante S, Londoni C, Brambilla G, Romeo S, Menozzi F, Griffanti P, Brandi G, Moreschi O, Pezzilli R, Zullo A, Buscarini E.. Premedication with simethicone and N-acetylcysteine for improving mucosal visibility during upper gastrointestinal endoscopy in a Western population. Endosc Int Open 2021; 9 (02): E190-E194 Epub 2021 Jan 25. PMID: 33532557; PMCID: PMC7834924