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

Upper Gastrointestinal Endoscopy Clinical Trial

— AERATE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06218537
• Other study ID #: AERATE
• Status: Recruiting
• Phase: N/A
• Start date: May 6, 2024
• Est. completion date: June 2024

Study information

• Verified date: May 2024
• Source: Carol Davila University of Medicine and Pharmacy
• Contact: Mihai Ciocirlan
• Phone: 0040722322625
• Email: ciocirlanm[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Upper Gastrointestinal Endoscopy

Intervention

Diagnostic Test:
• Test group
Contains protease from KREON capsules, activated by adding sodium bicarbonate.
• Control group
Contains only sodium bicarbonate.

Locations

Country	Name	City	State
Romania	"Agrippa Ionescu" Hospital	Bucharest

Sponsors (1)

Lead Sponsor	Collaborator
Carol Davila University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

References & Publications (6)

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. Erratum In: Gut. 2017 Dec;66(12 ):2188. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient satisfaction score	Patient satisfaction score assessed by a 10 points (0-10) visual analog scale	2 hours
Secondary	Endoscopist satisfaction score	Endoscopist satisfaction score assessed by a 10 points (0-10) visual analog scale	2 hours