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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2024-08-31

Brief Summary

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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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Detailed Description

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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

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Upper Gastrointestinal Endoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomly allocated in one of the 2 study groups, using a randomization list.

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.

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

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

One member of the team will prepare the two solutions, test and control solution, each 50 ml, and will give it to the patient, whithout the patient knowing what solution is. After 10 minutes, the investigator will perform upper GI endoscopy, also without him knowing what solution has been administered to the patient.

Study Groups

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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.

Group Type EXPERIMENTAL

Test group

Intervention Type DIAGNOSTIC_TEST

Contains protease from KREON capsules, activated by adding sodium bicarbonate.

Control group

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

Group Type SHAM_COMPARATOR

Control group

Intervention Type DIAGNOSTIC_TEST

Contains only sodium bicarbonate.

Interventions

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Test group

Contains protease from KREON capsules, activated by adding sodium bicarbonate.

Intervention Type DIAGNOSTIC_TEST

Control group

Contains only sodium bicarbonate.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No