"Agrippa Ionescu" Hospital
Bucharest, Romania
NCT Number: NCT06218537
The investigators aim to establish wether the administration of pancreatic enzyme replacement therapy (PERT) improves visibility of the mucosa during upper gastrointestinal endoscopy.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Bucharest, Romania
Upper gastrointestinal endoscopy is done "a jeun", without any solid foods at least 8 hours before procedure and no water at least 2 hours before procedure.
Often, the visibility of the mucosa is suboptimal due to presence of saliva which lay on the surface of the gastric mucosa forming small bubbles of foam and also the presence of mucus on the mucosal surface. Current strategies to improve mucosa visibility includes ingestion of simethicone, N-acetyl cysteine (N-ACC) an/or pronase, in different combinations, with 10 to 30 minutes before procedure. There are numerous comparative studies which shows their efficacy [1,2,3,4].
Although the guide of the European Society of Gastrointestinal Endoscopy (ESGE) [5] does not formally recommend these, the United Kingdom and the Australian guidelines do formally recommend them [6].
În România simethicone is available, but not pronase.
Research question of the protocol Does ingestion of a pancreatic protease (KREON 25000 UI) before upper GI endoscopy improves the visibility of the gastric mucosa.
Hypothesis Ingestion of a pancreatic protease (KREON 25000 UI) before upper GI endoscopy improves the visibility score of the gastric mucosa.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Contains protease from KREON capsules, activated by adding sodium bicarbonate.
Contains only sodium bicarbonate.
Time frame: 2 hours
The CSCS visibility score [4] will be assessed during upper GI endoscopy. For each of the 3 regions (fornix, gastric body and antrum) the maximum score is 3, so the maximum score is 9. An arbitrary cut-off value of less or equal than 5 for a suboptimal visibility has been chosen and higher than 5 for a satisfactory visibility.
Time frame: 2 hours
Patient satisfaction score assessed by a 10 points (0-10) visual analog scale
Time frame: 2 hours
Endoscopist satisfaction score assessed by a 10 points (0-10) visual analog scale
Carol Davila University of Medicine and Pharmacy
Other
Acronym: AERATE
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