Upper Gastrointestinal Endoscopy
Conditions
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.
Interventions
DIAGNOSTIC_TESTTest group
Contains protease from KREON capsules, activated by adding sodium bicarbonate.
DIAGNOSTIC_TESTControl group
Contains only sodium bicarbonate.
Sponsors
Carol Davila University of Medicine and Pharmacy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Crema Stomach Cleaning Score (CSCS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction score | 2 hours | Patient satisfaction score assessed by a 10 points (0-10) visual analog scale |
| Endoscopist satisfaction score | 2 hours | Endoscopist satisfaction score assessed by a 10 points (0-10) visual analog scale |
Countries
Romania
Outcome results
None listed