Evaluation of ultrasound image visualization ability of viscoclear

JRCT ID: jRCTs032240367

Registered date:01/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Digestive diseases
• Date of first enrollment: 01/10/2024
• Target sample size: 100
• Study type: Interventional
• Intervention(s): During endoscopic ultrasonography,inject approximately 200mL of water or Viscoclear into the observation area(upper limit:400mL)

Outcome(s)

• Primary Outcome: Ultrasound image visualization ability score

Secondary Outcome

(1)Average image score
(2)Image score distribution
(3)Image score agreement rate between evaluators
(4)Time from endoscope insertion to completion of ultrasound image depiction of the papilla of Vater
(5)Detection rate of incidental findings (diseases identified during endoscopic ultrasound examination other than the disease that triggered endoscopic ultrasound examination)
(6)Distribution of the degree of expansion evaluation of the papilla of Vater

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1)Patients aged 18 years or older at the time of informed consent
(2)Patients who can obtain written informed consent from themselves
(3)Patients undergoing endoscopic ultrasonography of the biliary tract and pancreas

Exclude criteria

(1)Patients with a history of total esophagectomy
(2)Patients with a history of total gastrectomy
(3)Patients with a history of pancreaticoduodenectomy
(4)Patients who fall under the contraindications and prohibitions listed in the Viscoclear package insert below
-Patients with a history of hypersensitivity to the components of this product
-Patients with confirmed or suspected gastrointestinal perforation
(5)Patients who are pregnant,breastfeeding,or may be pregnant
(6)Patients who deemed ineligible for the study

Related Information

• Primary Sponsor: Fujiya Mikihiro
• Secondary Sponsor: Kamoshita Satoru,Otsuka Pharmaceutical Factory, Inc. Medical Affairs Department