Clinical trial NCT06218537: The Role of oAncreatic Enzyme ReplAcement Therapy (PERT) on Mucosal Visibility Before Upper GI Endoscopy
Official title: The Role of oAncreatic Enzyme ReplAcement Therapy (PERT) on Mucosal Visibility Before Upper GI Endoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Gastrointestinal Endoscopy
Lead sponsor: Carol Davila University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: DIAGNOSTIC

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Crema Stomach Cleaning Score (CSCS)
timeFrame: 2 hours
Secondary outcomes:
measure: Patient satisfaction score
timeFrame: 2 hours
measure: Endoscopist satisfaction score
timeFrame: 2 hours
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: "Agrippa Ionescu" Hospital
Study officials:
References:
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.
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.
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.
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.
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.
citation: 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.