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Effectiveness of Gallbladder Drainage with a 0.81-mm Guidewire

Prospective Observational Study on the Utility of Endoscopic Ultrasound-Guided Gallbladder Drainage (EUS-GBD) Using a 0.81-mm Guidewire - Prospective Observational EUS-GBD with 0.81-mm GW Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000056960
Enrollment
35
Registered
2025-02-06
Start date
2025-02-06
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

Acute Cholecystitis

Interventions

None listed

Sponsors

Yokohama City Minato Red Cross Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients diagnosed with acute cholecystitis who require gallbladder drainage. Patients with moderate acute cholecystitis or mild cases that do not respond to initial treatment. Patients with a Performance Status (PS) Grade of 0-4. Patients aged 18 years or older at the time of consent. Patients who have received a thorough explanation of the study, fully understood its details, and provided written informed consent voluntarily.

Exclusion criteria

Exclusion criteria: Patients with severe cholecystitis, as defined by the Tokyo Guidelines 2018. Patients with concomitant cholangitis due to bile duct stones. Patients with a history of gastrectomy (Billroth I reconstruction, Billroth II reconstruction, or Roux-en-Y reconstruction). Patients with unstable respiratory or circulatory status. Patients receiving long-term steroid therapy. Patients with severe ascites. Patients with a severe bleeding tendency. Patients with severe cardiac disease. Pregnant or lactating women, or those who may be pregnant. Patients deemed inappropriate for the study by the principal investigator or sub-investigators.

Design outcomes

Primary

MeasureTime frame
To evaluate the effectiveness and safety of endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using a 0.81-mm guidewire for acute cholecystitis and to assess the insertion rate of a 7Fr plastic stent among all cases.

Secondary

MeasureTime frame
Technical success rate of EUS-GBD without fistula dilation Clinical success rate Adverse event rate Length of hospital stay Stent patency duration during the observation period

Countries

Japan

Contacts

Public ContactHidenobu Hara

Yokohama City Minato Red Cross Hospital Gastroenterology

hidenobu1005_0406@yahoo.co.jp0456286100

Outcome results

None listed

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