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

Not Applicable

Completed

• Conditions: Upper Gastrointestinal Endoscopy
• Interventions: Diagnostic Test: Test group; Diagnostic Test: Control group

• Registration Number: NCT06218537
• Lead Sponsor: Carol Davila University of Medicine and Pharmacy

Brief 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.

Study Timeline

• Study First Submitted: 2024-01-12
• Study First Submitted QC: 2024-01-12
• Study First Posted: 2024-01-23
• Study Start: 2024-08-01
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-09
• Last Update Posted: 2024-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• patient with upper gastrointestinal endoscopy indication, with topical pharyngeal anesthesia
• age above 18 years old
• informed consent

Exclusion Criteria

• allergy to KREON and/or sodium bicarbonate
• upper gastrointestinal bleeding clinically manifest (hematemesis, melena, hematochesia)
• ingested foreign body
• personal history of esophagectomy, partial or total gastectomy
• absence of informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group	Test group	The test group - 10 minutes before upper GI endoscopy, patients will drink a solution of 50ml water + 2 capsules of KREON 25000 UI, opened (with minimicrospheres, pellets) + 1.2g sodium bicarbonate, mixed. Adding sodium bicarbonate is necessary to dissolve the minimicrospheres of KREON.
Control group	Control group	The control group - 10 minutes before upper GI endoscopy, patients will drink a solution of 50ml water + 1.2g sodium bicarbonate, mixed.

Primary Outcome Measures

Name	Time	Method
Crema Stomach Cleaning Score (CSCS)	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.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction score	2 hours	Patient satisfaction score assessed by a 10 points (0-10) visual analog scale
Endoscopist satisfaction score	2 hours	Endoscopist satisfaction score assessed by a 10 points (0-10) visual analog scale

Trial Locations

Locations (1)

"Agrippa Ionescu" Hospital; 🇷🇴 Bucharest, Romania