Evaluation of ultrasound image visualization ability of viscoclear

Evaluation of the ultrasound image visualization ability and safety of gel immersion for patients undergoing endoscopic ultrasonography near the papilla of Vater : Multicenter, single-blind, randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs032240367

Enrollment

100

Registered

2024-10-01

Start date

2024-12-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digestive diseases

Interventions

During endoscopic ultrasonography,inject approximately 200mL of water or Viscoclear into the observation area(upper limit:400mL)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Ultrasound image visualization ability score	—

Secondary

Measure	Time frame
(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	—

Measure

Time frame

(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

—

Contacts

Public ContactHidemasa Kawabata

Asahikawa Medical University

kawa0527@asahikawa-med.ac.jp+81-166-68-2462

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026