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

Carol Davila University of Medicine and Pharmacy

Status: Completed

Conditions: Upper Gastrointestinal Endoscopy

Treatments: Diagnostic Test: Control group; Diagnostic Test: Test group

Study type: Interventional

Funder types: Other

Identifiers

NCT06218537

AERATE

Details and patient eligibility

About

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

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups

Test group

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Test group

Control group

Sham Comparator group

Description:

The control group - 10 minutes before upper GI endoscopy, patients will drink a solution of 50ml water + 1.2g sodium bicarbonate, mixed.

Treatment:

Diagnostic Test: Control group