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OpenTrials
Completed

NCT Number: NCT06218537

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

"Agrippa Ionescu" Hospital

Bucharest, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Test group

Diagnostic Test

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

Control group

Diagnostic Test

Contains only sodium bicarbonate.

Primary outcomes

  1. Crema Stomach Cleaning Score (CSCS)

    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.

Secondary outcomes

  1. Patient satisfaction score

    Time frame: 2 hours

    Patient satisfaction score assessed by a 10 points (0-10) visual analog scale

  2. Endoscopist satisfaction score

    Time frame: 2 hours

    Endoscopist satisfaction score assessed by a 10 points (0-10) visual analog scale

Sponsors and collaborators

Lead sponsor

Carol Davila University of Medicine and Pharmacy

Other

Registry information

Acronym: AERATE

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 23, 2024
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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