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

NCT06218537 | Completed

• 1 other identifier: AERATE
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Gastrointestinal Endoscopy

Outcome Measures

Primary Outcomes (1)

• Crema Stomach Cleaning Score (CSCS)

  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.

  2 hours

Secondary Outcomes (2)

• Patient satisfaction score

  2 hours

• Endoscopist satisfaction score

  2 hours

Study Arms (2)

Test group

EXPERIMENTAL

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.

Diagnostic Test: Test group

Control group

SHAM COMPARATOR

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

Diagnostic Test: Control group

Interventions

Test group DIAGNOSTIC_TEST

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

Test group

Control group DIAGNOSTIC_TEST

Contains only sodium bicarbonate.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carol Davila University of Medicine and Pharmacy: lead

Study Sites (1)

"Agrippa Ionescu" Hospital

Bucharest, Romania

Location

Related Publications (6)

• Kuo CH, Sheu BS, Kao AW, Wu CH, Chuang CH. A defoaming agent should be used with pronase premedication to improve visibility in upper gastrointestinal endoscopy. Endoscopy. 2002 Jul;34(7):531-4. doi: 10.1055/s-2002-33220.

  PMID: 12170403 BACKGROUND

• Chen HW, Hsu HC, Hsieh TY, Yeh MK, Chang WK. Pre-medication to improve esophagogastroduodenoscopic visibility: a meta-analysis and systemic review. Hepatogastroenterology. 2014 Sep;61(134):1642-8.

  PMID: 25436356 BACKGROUND

• Li Y, Du F, Fu D. The effect of using simethicone with or without N-acetylcysteine before gastroscopy: A meta-analysis and systemic review. Saudi J Gastroenterol. 2019 Jul-Aug;25(4):218-228. doi: 10.4103/sjg.SJG_538_18.

  PMID: 31044749 BACKGROUND

• Manfredi G, Berte R, Iiritano E, Alicante S, Londoni C, Brambilla G, Romeo S, Menozzi F, Griffanti P, Brandi G, Moreschi O, Pezzilli R, Zullo A, Buscarini E. Premedication with simethicone and N-acetylcysteine for improving mucosal visibility during upper gastrointestinal endoscopy in a Western population. Endosc Int Open. 2021 Feb;9(2):E190-E194. doi: 10.1055/a-1315-0114. Epub 2021 Jan 25.

  PMID: 33532557 BACKGROUND

• Bisschops R, Areia M, Coron E, Dobru D, Kaskas B, Kuvaev R, Pech O, Ragunath K, Weusten B, Familiari P, Domagk D, Valori R, Kaminski MF, Spada C, Bretthauer M, Bennett C, Senore C, Dinis-Ribeiro M, Rutter MD. Performance measures for upper gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy. 2016 Sep;48(9):843-64. doi: 10.1055/s-0042-113128. Epub 2016 Aug 22. No abstract available.

  PMID: 27548885 BACKGROUND

• Beg S, Ragunath K, Wyman A, Banks M, Trudgill N, Pritchard DM, Riley S, Anderson J, Griffiths H, Bhandari P, Kaye P, Veitch A. Quality standards in upper gastrointestinal endoscopy: a position statement of the British Society of Gastroenterology (BSG) and Association of Upper Gastrointestinal Surgeons of Great Britain and Ireland (AUGIS). Gut. 2017 Nov;66(11):1886-1899. doi: 10.1136/gutjnl-2017-314109. Epub 2017 Aug 18.

  PMID: 28821598 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Așsociate Professor of Gastroenterology

Model Details: 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.

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 23, 2024
• Study Start: August 1, 2024
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)