Mucolytic Solution Before Upper Endoscopy

Gastroscopy; Gastric Cancer Clinical Trial

Official title:

The Use of Mucolytic Solution Before Upper Endoscopy: A Randomized, Double-blinded Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02967094
• Other study ID #: DDC VN 09
• Status: Recruiting
• Phase: N/A
• First received: November 10, 2016
• Last updated: November 27, 2016
• Start date: November 2016
• Est. completion date: May 2017

Study information

• Verified date: November 2016
• Source: Vitkovice Hospital
• Contact: Premysl Falt, M.D., Ph.D.
• Phone: +420595633
• Email: faltprem[@]centrum.cz
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Study was designed to evaluate efficacy of mucolytic solution ingested before upper endoscopy on visibility of gastric mucosa.

Description:

Residual gastric content containing mucus, bubbles, bile and food particles may limit visibility of gastric mucosa and therefore diagnostic yield of upper endoscopy, especially in cases of early neoplastic lesions. Data on benefit of peroral mucolytic solution administered before upper endoscopy are limited.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age > 18 years

• signed informed consent

• diagnostic gastroscopy

Exclusion Criteria:

• age < 18 years

• interventional gastroscopy

• known disease of the upper GI tract and/or history of surgery of GI tract

• gastroscopy indicated of bleeding, dysphagia or ileus

• liver cirrhosis

• general anesthesia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Gastroscopy; Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Administration of mucolytic solution before upper endoscopy (Espumisan, ACC long)

• Administration of water before upper endoscopy

Locations

Country	Name	City	State
Czech Republic	Digestive Diseases Center	Ostrava

Sponsors (1)

Lead Sponsor	Collaborator
Vitkovice Hospital

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"Visibility score" evaluated by blinded performing endoscopist	"Visibility score" (0-25 points) counted as the sum of visibility score in the esophagus (0-5), fundus (0-5), corpus (0-5) and atrum (0-5) of the stomach and in the duodenum (0-5).	through study completion, an average of 3 months	No
Secondary	"Visibility score" evaluated by three blinded endoscopists using 11 endoscopic images captured during endoscopy.	"Visibility score" (0-25 points) counted as the sum of visibility score in the esophagus (0-5), fundus (0-5), corpus (0-5) and atrum (0-5) of the stomach and in the duodenum (0-5).	through study completion, an average of 3 months	No
Secondary	Residual fluid in the stomach evaluated by blinded performing endoscopist	0-3 point scale	through study completion, an average of 3 months	No
Secondary	Duration of endoscopy	time between introduction and withdrawal of the endoscopy	through study completion, an average of 3 months	No