NCT06218537

The Role of oAncreatic Enzyme ReplAcement Therapy (PERT) on Mucosal Visibility Before Upper GI Endoscopy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Carol Davila University of Medicine and Pharmacy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators aim to establish wether the administration of pancreatic enzyme replacement therapy (PERT) improves visibility of the mucosa during upper gastrointestinal endoscopy.

Detailed description

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.

Conditions

• Upper Gastrointestinal Endoscopy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Test group	Contains protease from KREON capsules, activated by adding sodium bicarbonate.
DIAGNOSTIC_TEST	Control group	Contains only sodium bicarbonate.

Timeline

• Start date: 2024-08-01
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2024-01-23
• Last updated: 2024-11-12

Locations

1 site across 1 country: Romania